Syneos Health

Description Accounts Payable Coordinator I (Travel & Expense) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®. Discover what our 29,000 employees, across 110 countries already know. WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities The Expense Report Auditor will join a team who service the expense reporting needs of Syneos Health. This position is responsible for applying Syneos Travel Policy, Client Travel Policies, and Business Conduct Standards while performing a variety of expense report and auditing functions. Most tasks will involve processing and auditing expense reports while promoting a customer service environment by responding effectively to employee inquiries in a prompt, accurate, and professional manner. Duties may include, but not limited to: Job Responsibilities: Audit selected expense reports and related receipts in accordance Travel and Expense Policy and Business Conduct Standards and approve for payment. Collect, analyze, and interpret information to assess and conclude on each assigned audit area. Prepare clear and concise documentation to adequately support all audit area conclusions and findings. Monitor and complete problematic expense reports that are in a pending status waiting for additional research and resolution. Review previous audit annotations, reports, approvals, and additional on-file information. Regularly monitor and respond to Expense Reporting voicemail and email. Respond to a high volume of employee inquiries in a prompt, accurate, and professional manner. Correctly answer employee questions regarding system issues, Travel Policy, and Business Conduct Standard reimbursement guidelines. Assist in identifying improvement opportunities and shares best practices within department. Assist in identifying potential partnerships between Expense Reporting and the various functional areas and business units throughout the Company. Cross train to perform back up functions for higher-level accounting clerks as directed or assigned. Produce required daily, weekly, and monthly reports relating to expense report auditing. Qualifications Bachelor’s degree required (Preferably in Commerce) Required 1-2 years of Travel & Expense process and Expense audit experience. Preferred to have experience on any expense tool like Concur / I-Expense/Workday etc. Expense audit experience is a preference Customer service experience Strong oral and written communication skills Proficient at Microsoft Excel and PowerPoint Ability to perform day-to-day functions with limited supervision; ability to interact comfortably with individuals from various business units. Good analytical skills and a strong attention to detail. Impeccable organization skills, strong interpersonal skills and the flexibility to handle multiple tasks simultaneously. Strong Customer Relation Skills. Strong Math Aptitude. Time Management Skills. Able to work independently and as part of a team. Problem solving ability. Flexible and able to adapt to shifting priorities and responsibilities in a dynamic and changing environment. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Show more Show less

Description VP, AI and Engineering Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®. Discover what our 29,000 employees, across 110 countries already know. WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Job Summary: This role is responsible for leading the AI, software, data, and quality engineering organization. Accountable for delivering best in class AI, data, and applications used by thousands of users worldwide. The engineering organization will partner with digital and technology product teams to create solutions and value for customers, solutions that help accelerate medicines and vaccines development and enable patient access. The role drives and delivers AI-infused applications at scale that will support Syneos Health’s efficient growth. The engineering organization also develops technology products that supercharge internal capabilities across corporate functions. Builds and develops the engineering organization based in India and leads a network of engineering nodes in other locations around the world. Participates in customer meetings, conferences, and technology incubators with a focus on building relationships, tracking trends, and engaging with peers in the industry. As a senior digital and technology leader in India, the role is responsible for overseeing daily operations (technology and people) for the delivery team, technology development, and strategic growth of the company’s regional offices. This leadership role focuses on driving the implementation of global technology initiatives, ensuring operational alignment with global standards, and fostering a high-performance culture within the team. Plays a key role in talent management, project delivery, stakeholder communication, and driving innovation to support the company's global goals. Core Responsibilities Develop Best in Class and Cost Engineering Organization Attract, Develop, and Retain engineering talent across all disciplines including AI, software, data analytics, quality, testing, and agile facilitation. Manage and scale a team of technology professionals, ensuring the right mix of talent to meet business demands. Continuously upskill organization on new technologies in alignment with enterprise technology decisions. Manage strategic 3rd parties to access engineering talent and source capacity when internal capabilities are fully utilized. Assess maturity of organization, set path to implement best practices and standards for engineering disciplines, and lead communities of practice. Oversee and manage a High-Performing Technology Delivery Partner with digital and tech product leaders to understand priorities, manage demand, provide work estimates, and maintain product roadmaps. Staff engineering resources on product and project teams to deliver prioritized initiatives, ensuring utilization of organization. Deliver coding, configuration, and testing in product-centric and agile ways and measure performance quarterly across value, flow, and quality metrics. Where needed, staff and deliver projects. Drive Devops, Dataops, and MLops platforms and engineering productivity, AI automation, automated code and test, in partnership with Core Technology. Regional Tech Leadership: Lead and manage the day-to-day operations of the site-based team, ensuring alignment with the global strategic objectives. Provide site leadership across technology projects end to end, including software development, product delivery, infrastructure management, and IT services. Monitor industry trends, emerging technologies, and best practices to ensure the site remains competitive and innovative. Foster a culture of collaboration, innovation, and continuous improvement within the site. Build, mentor, and inspire a high-performing team, ensuring the growth and development of employees. Drive employee engagement and retention initiatives to ensure a motivated and committed workforce. Partner with HR and Talent Acquisition in support of these initiatives for an engaged and sought after employee experience. Stakeholder Communication: Maintain strong relationships with key stakeholders in the CDIO LT, including senior leadership, product, and engineering teams. Provide regular updates on performance, delivery progress, risks, and opportunities to CDIO executives. Act as a cultural ambassador, ensuring that the team’s work aligns with the company’s global vision and values. Risk Management and Compliance: Ensure the organization complies with relevant legal, regulatory, and company policies. Identify risks related to technology, operations, and talent management, and implement mitigation strategies. Innovation and Continuous Improvement: Promote and drive innovation within the team, encouraging the use of new technologies and approaches. Continuously assess and improve site processes to enhance efficiency, reduce costs, and drive value. Qualifications Experience in technology or operations leadership roles, with experience managing a tech team in a region or a similar market. Experience leading a pharma services technology organization (CRO, professional services, biotech/biopharma, and healthcare technology) focused on life sciences. Proven track record in leading cross-functional teams and delivering complex end to end technology projects at a global scale. Experience leveraging data, analytics, and AI to develop new products and services. Ability to transform legacy technology and digital teams into a highly efficient, disciplined, delivery-oriented organization with strong alignment to business strategy. Experience managing both technical and operational aspects of a global business, particularly with teams in different geographic locations. P&L experience is a plus. Proven experience to lead a high-performing team as well as attracting talent for a continuous cycle of diversity of thought tied to employee growth and business objectives being met. Experience leading a technology organization providing both product development and SaaS Software solutions for a broad range of technologies such as Python, Java, Apex, Databricks, Workday, Oracle Fusion, ServiceNow, SalesForce, Veeva CRM, Veeva Vault Clinical, as well as cloud and analytical services provided by Microsoft Azure, AWS, Oracle OCI is preferred. Strong leadership and team-building abilities. Excellent communication and interpersonal skills, with the ability to effectively interact with senior management, technical teams, and global stakeholders. Deep understanding of modern software, AI, and data development methodologies, including Agile methodologies, devops, dataops, and MLops. Proficiency in technology management, project delivery, and risk mitigation. Strong business acumen, including the ability to manage budgets, resources, and operational performance. Strong problem-solving skills and a proactive approach to resolving challenges. Ability to work in a fast-paced, dynamic environment. Experience in a global or multi-site organization is highly desirable. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Show more Show less

Description Medical Writer I Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Compiles, writes, and edits medical writing deliverables, and serves as medical writer within and across departments with moderate supervision. Develops or supports, a variety of documents that include but not limited to: o Clinical study protocols and clinical study protocol amendments; o Clinicalstudy reports; o Patient narratives; o Investigator brochures. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content and for grammar, format, and consistency. Provides feedback to further define statistical output required. Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables. Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget. Performs on-line clinical literature searches, as applicable. Continues professional development to keep pace with regulatory guidance and client expectations that affect medical writing and to improve skills. Is aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership. Completes required administrated tasks within the specified timeframes. Performs other work-related duties as assigned. Minimal travel may be required (less than 25%). Qualifications 1. Any Life Science postgraduate-Prefer M.Pharm,PharmD 2. Candidates having experience in Clinical Trial Disclosure, Regulatory Medical Writing, Pharmacovigilance (Safety Narrative Writing). 3. Responsibilities include drafting CTD documents for clients and performing quality checks (QC) documents 4. Preferred experience with results posting for regulatory bodies such as US FDA, ClinicalTrials.gov (ct.gov), EUCTR 0. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Show more Show less

Description Safety & PV Specialist I-Japanese -Pune Office Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required. Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required. Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability. Enters data into safety database. Codes events, medical history, concomitant medications, and tests. Compiles complete narrative summaries. Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved. Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements. Maintains safety tracking for assigned activities. Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required. Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA. Manual recoding of un-recoded product and substance terms arises from ICSRs. Identification and management of duplicate ICSRs. Activities related to SPOR / IDMP. Quality review of ICSRs. Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate. Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process. Fosters constructive and professional working relationships with all project team members, internal and external. Participates in audits as required/appropriate. Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities. Qualifications Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Show more Show less

Description Regulatory / Sr Regulatory Associate (Module 1, regulatory submission) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Qualifications Job Responsibilities Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Show more Show less

Description Global Feasibility Lead Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Works independently with little to no oversight towards RFP and standalone paid feasibility objectives. Confidently assesses the level of data and analysis required and proposes approaches for RFPs and individual paid feasibility assessments. Ability to manage an average number of assignments and complexity concurrently Proactively identifies solutions to non-standard requests. Applies knowledge/skills to a range of moderately complex activities. Independently liaises with internal stakeholders to review sponsor requirements, protocol, and timelines for individual RFPs. Upon discretion of a line manager, may participate in and support activities related to department staff operations. No project oversight expected, some limited mentoring upon discretion of the Line Manager may be expected. May coordinate work of other team members as needed during multi study programs of studies or mentoring period(s). Supports department management in development of group and achieving business objectives. Liaises with Business Units, Business Development, Medical Directors, Business Analysts, and other members of the team to review sponsor requirements, protocol, and timelines for individual RFPs. Independently manages and performs research of scientific literature using internet and internal metrics and tools to provide background information. May support the preparation of material for and attends bid defense teleconferences and meetings, under review and supervision of a line manager or delegate. Actively participates in developing relevant metrics to measure the impact of protocol feasibility assessments, recruitment support, and site identification and selection activities. Maintains comprehensive records of work and stores all relevant data within internal libraries in a timely manner. May help support development of feasibility analysis systems and support collection of associated metrics. May develop and maintain systems for storage and retrieval and analysis of historical feasibility data in support of current RFPs and RFIs. Review, analysis and delivery of pre-award site level feasibility assessments into presentations and/or written reports for delivery to internal/external stakeholders May participate in the evaluation of new informatics technologies, such as clinical trial registry search tools, enrollment modeling and simulation tools and protocol feasibility assessment tools. Excellent English verbal and written communication skills. Build and maintain relationships with internal and external stakeholders to develop clear communication methods to support study strategies aimed at becoming the subject matter expert (SME). Qualifications Preferred BS/BA in Science with an emphasis in medical research Working independently in a virtual team environment Understanding and presenting complex scientific and clinical research data and analysis methodologies Knowledge of principles, concepts, practices, and standards in the CRO industry Effective sales and bid text development Working and managing individuals and data to drive business objectives Attention to detail Mentoring and training capabilities Advanced Microsoft Office Suite (e.g., Word, Excel, PowerPoint, database applications), email, and internet research capabilities. Strong organizational, interpersonal, and team-oriented skills Excellent verbal and written English communication proficiency. Superior time management skills; ability to perform several tasks simultaneously to meet deadlines in a dynamic environment Ability to be flexible, adapt to change, as wellas work collaboratively as part of a team Must be flexible around travel and work hours if a business need should arise. Travel minimum of 5% Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Show more Show less

Description Cybersecurity Solutions Architect Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®. Discover what our 29,000 employees, across 110 countries already know. WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities JOB SUMMARY The Cyber Security Solution Architect will be responsible for transforming the way Syneos Health protects applications, software and code that it uses to support the company to accelerate patient therapies to market and thereby increase cyber threat resiliency. This role will be a member of the Office of the CISO and a member of enterprise security architects. As a key subject matter expert and leader within the team, this role will use a data and risk-based approach to driving enterprise initiatives, formulating requirements, patterns, and solutions to achieve risk mitigation. To be successful, this role will act as a technical influencer, build cross-functional and organizational partnerships to deliver modern security engineering and operational solutions. As an architect you will partner with the software engineering organization to design software security solutions, participate in proof of concepts and enable the engineering organization to deliver secure, operational solutions. The role will own the software security program and initiatives and be responsible for reporting on progress to leadership and stakeholders. The scope of responsibility includes but not limited to supporting the transformation of security engineering into the early phases of enterprise delivery through defined Secure SDLC, Source code management, application security, and the transformation of DevSecOps across the enterprise. The role will bring an everything-as-code security mindset to be applied across applications, API’s and platform engineering. To be successful, the role will need to define and identify technical and business risks along with enterprise requirements that can be consumed by a shared-responsibility model for engineering and operational controls. Be a transformation agent by advocating for modern secure engineering principles and automation. Excellent oral and written communication skills, as well as effective organizational abilities, are essential due to the detailed and time-bound nature of the work and the extensive collaboration with others. Job Responsibilities Mature and modernize the enterprise software security program and initiatives to manage risks and enable technology solutions: Use a data-driven approach to identifying areas of risk Publish metrics and KPI’s Set enterprise requirements for secure software development based on common cyber security frameworks such as NIST, Hitrust, CSF. SafeCode, OWASP etc Contribute to enterprise security policies and standards. Evolve Secure SDLC standards and processes Define, own, and drive the company's software security strategy and roadmap, acting as the key security voice for software security Partner with software and platform engineering teams to: Promote DevSecOps solutions and culture Establish secure code management practices Improve automated CI/CD pipelines with appropriate security services Automate enterprise security requirements into backlogs Champion cloud application and platform security engineering practices. Delivery enterprise security patterns for software engineering Participate in Proof of Concepts with the software engineering organization . Educate and drive engagement of modern secure software principles within the organization by: Being a strategic advisor in software security. Being a transformation agent in promoting a modern security engineering mindset. Performing design reviews to identify security architecture flaws. Qualification Requirements What we are looking for: 5–7 years of experience in software security or related roles. Proven track record building and transforming secure software and platform engineering practices Building road maps and creating initiatives to address enterprise goals. Experience partnering with engineering teams to achieve security goals. Strong familiarity with source code management Strong familiarity software exploitation techniques and Mitre @ttack framework. Strong knowledge of cloud platform security (AWS, Azure, Oracle Infrastructure Cloud) Someone with strong engineering mindset that software engineering experience Experience implementing pipeline automation and source code management Additional Standout Skills Hands-on experience with modern engineering technologies such as Kubernetes and Containers Experience with securing Terraform or other IaC platforms Delivered secure coding practices to large engineering teams Familiar with API Security Enabling DevSecOps within large organizations Education. Security Architecture TOGAF/SABSA Cloud security certifications for OCI, AWS or Azure (Azure preferred) Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary JOB SUMMARY The Cyber Security Solution Architect will be responsible for transforming the way Syneos Health protects applications, software and code that it uses to support the company to accelerate patient therapies to market and thereby increase cyber threat resiliency. This role will be a member of the Office of the CISO and a member of enterprise security architects. As a key subject matter expert and leader within the team, this role will use a data and risk-based approach to driving enterprise initiatives, formulating requirements, patterns, and solutions to achieve risk mitigation. To be successful, this role will act as a technical influencer, build cross-functional and organizational partnerships to deliver modern security engineering and operational solutions. As an architect you will partner with the software engineering organization to design software security solutions, participate in proof of concepts and enable the engineering organization to deliver secure, operational solutions. The role will own the software security program and initiatives and be responsible for reporting on progress to leadership and stakeholders. The scope of responsibility includes but not limited to supporting the transformation of security engineering into the early phases of enterprise delivery through defined Secure SDLC, Source code management, application security, and the transformation of DevSecOps across the enterprise. The role will bring an everything-as-code security mindset to be applied across applications, API’s and platform engineering. To be successful, the role will need to define and identify technical and business risks along with enterprise requirements that can be consumed by a shared-responsibility model for engineering and operational controls. Be a transformation agent by advocating for modern secure engineering principles and automation. Excellent oral and written communication skills, as well as effective organizational abilities, are essential due to the detailed and time-bound nature of the work and the extensive collaboration with others. Show more Show less

Description Accounts Payable Coordinator I Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®. Discover what our 29,000 employees, across 110 countries already know. WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health: We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for, and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Description: The Expense Report Auditor will join a team who service the expense reporting needs of Syneos Health. This position is responsible for applying Syneos Travel Policy, Client Travel Policies, and Business Conduct Standards while performing a variety of expense report and auditing functions. The majority of tasks will involve processing and auditing expense reports while promoting a customer service environment by responding effectively to employee inquiries in a prompt, accurate, and professional manner. Duties may include, but not limited to: Job Responsibilities: Payment Processing Run payment batches (e.g., PPR – Payment Process Request) Monitor payment statuses and resolve errors Validate payment files before transmission Payment Formats Understand seeded formats (e.g., NACHA, SEPA, ISO20022) Assist in testing and validating custom formats Reconciliation Support Help with bank statement uploads Match payments with bank transactions Issue Resolution Investigate payment rejections or failures Log and track issues using internal ticketing systems Review AP share mailbox for invoices and approval based upon assignment Review AP share mailbox for inquires based upon assignment and respond within 48 hours; urgent request within 24 hours to vendor and/or internal customer Ensures all types of payments (check, ACH, wires) are made in a timely manner and are corded in Oracle accounts payable system Ensures proper approvals are included on all payments to be processed Creates check runs, EFT and wire payment batches, including preliminary register Reviews printed checks for accuracy and signatures Investigation of aged creditor balances exceeding supplier payment terms and collection of credit balances owing Assists in month end closing preparing monthly accruals Maintains files and documentations thoroughly and accurately, in accordance with company policy and accepted accounting practices. Comply with process controls outlined in narratives to meet Sarbanes-Oxley internal controls objectives. Maintain Update SOP’s and operating guidelines timely. Maintain Learning Logs Follow up on invoices under queries, on hold and pending with approvers Reviewing payment exceptions & on hold documents. Qualifications Prior Accounts Payable experience for 01 to 03 Years in Payment Processing Hands-on experience in query resolution and reconciliation Strong Excel skills – at least intermediate level Experience of working in a multi-currency environment Strong organizational skills Good communication skills Ability to communicate well when working with colleagues/clients in other countries Attention to detail and accuracy Desirable: Experience of using Oracle ERP system Get To Know Syneos Health: Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Show more Show less

Description Safety Physician - ICSR Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Performs medical review of adverse events reported for investigational and marketed products Maintains familiarity with MedDRA, WHO-DRL, and safety databases such as ARGUS. Works closely with Safety and Pharmacovigilance (SPVG) colleagues to ensure appropriate medical interpretation and consistency are applied to adverse event case assessment Ensures regulatory and SOP compliance with respect to evaluation, reporting and surveillance of clinical and post-marketing safety information Identifies, communicates and effectively manages potential safety issues Interacts with client’s safety/medical personnel as appropriate Stays abreast of clinical and drug development information relevant to contracted programs Provides medical review and interpretation for aggregate safety reports (e.g. annual safety reports, PSURs, PADERs) Maintains medical and pharmacovigilance expertise through appropriate internal or external continued medical education Assists as a mentor and trainer for other internal safety staff including case processing staff Responsible for performing activities that are in compliance with applicable Corporate and D Departmental Policies, Standard Operating Procedures, Work Instructions and any project specific Operating Guidelines Performing other duties as assigned by management. Qualifications The incumbent should possess M.D., MBBS, D.O. Completed an accredited residency; Minimum of one to two (1 to 2) years of experience in clinical practice Minimum of one year of experience in the pharmaceutical, biotechnology, or device industry working in pharmacovigilance/epidemiology preferred Knowledge of global pharmacovigilance regulations and processes Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace), safety databases, and internet. Excellent verbal and written communication skills (proficient in English) as well as in the language required for case processing Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform and influence Ability to travel as necessary (up to 10%) Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Show more Show less

Description Sr Medical Editor Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Maintains familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance. Represents the editorial group in Medical Writing, on study teams, and in cross-departmental project teams as needed. Monitors timelines and budgets for assigned projects and updates the Lead Medical Writer, Project Manager, and/or direct supervisor (as appropriate) if deliverables are at risk. Provides technical support and expertise as appropriate. Conducts training of medical editing staff and functions as a mentor. Advises medical writers, medical editors, and study teams on data integrity review, compilation, publishing, and editorial standards. Provides training to members of the global Medical Writing team in aspects relative to their roles. Project lead for deliverables of assigned complex and/or large medical writing projects, including but not limited to scheduling and leading internal project-specific team meetings, organizing project-specific requirements, and ensuring that all information is distributed to the editorial team and implemented within the deliverable. Serves as a member of the medical writing team for projects with medical writing deliverables. Provides feedback to the lead medical writer on progress of document editorial process. Copyedits assigned documents, applying correct grammar, punctuation, spelling, and style following American Medical Association (AMA) or various custom style guidelines as well as established medical writing internal checklists and best practices. Performs data integrity review of assigned documents to ensure accuracy. Contributes to the development of process improvement tools and the development or revision of internal policies and procedures affecting editorial work. Manages assigned projects according to medical writing standard operating procedures and client standards, on time and on budget. May compile and publish medical writing deliverables. Qualifications Bachelor’s degree (preferred) in the life sciences, clinical sciences, or English/journalism; or copyediting, data integrity review, and/or relevant publishing experience. Significant relevant publishing experience using Adobe Acrobat or other appropriate markup language preferred; ISIToolbox experience preferred. Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). Excellent attention to detail, including strong copyediting, data integrity review, accuracy, problem solving, organizational, interpersonal, presentation, project management, and team-oriented skills. Excellent grammatical and communication skills, both written and oral. Extensive familiarity with the AMA style guide strongly preferred. Ability to work with minimal supervision on multiple assignments with set deadlines. Ability to work independently as well as part of a team and keep others informed of the progress and statusof projects. Adaptable to changes in work duties, responsibilities, and requirements. Knowledge of FDA and EU requirements, ICH regulations and ISO standards as applicable to regulatory documents preferred. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Should have min 5+ yrs of medical editing experience Should have good experience of copyediting or publishing experience Show more Show less

Job Title: Payroll Specialist Business Unit/Department: Finance/Corporate Hiring Timeline: Immediate Location: Gurgaon Work Schedule: Fixed hours from 9:00 AM to 10:00 AM; mandatory 9-hour shift (Onsite/Hybrid role) Day-to-Day Responsibilities: End-to-end payroll processing and administration Checking and validation of PF reports Dealing with EPFO office/payroll vendor to resolve PF issues of employees Maintaining payroll reports Performing payroll tax calculations, deductions, and submissions to ensure compliance with local and state regulations Ensuring vendors make statutory payments on time Collaborating with cross-functional teams (HR, Finance & Vendors) Following India payroll processes and practices Desired Skills and Background: 1 to 3 years of India Payroll experience Experience with Joint Declaration Form for Provident Fund (PF) to correct or update employee details in the EPFO records Proficiency in MS Excel (basic formulas) Report generation experience Good communication skills

Description Sr Statistical Programmer SDTM, ADAM & TLFs Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities, Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for, Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives, Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program, We are committed to our Total Self culture where you can authentically be yourself Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people, We are continuously building the company we all want to work for and our customers want to work with WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives were able to create a place where everyone feels like they belong, Job Responsibilities Uses SAS or other software to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications, Works to ensure that outputs meet quality standards and project requirements, Performs validation programming and works with other Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings, Keeps project team members informed of programming progress and issues requiring their attention, Follow applicable SOPs, WIs, and relevant regulatory guidelines (e-g ICH), Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness, Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload, Develops specifications for datasets and outputs of any complexity according to statistical and sponsor requirements Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines allvariables to be accepted by peer review and sponsor/requestor with little rework, Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others, Conducts effective internal meetings (appropriate in format, frequency and attendance) Distributes relevant information in advance Ensures minutes are promptly and accurately distributed Follows action items through to completion, and maintains order and focus of meetings, working toward consensus, Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business, Negotiates and establishes accurate time estimates for completion of study programming activities with internal team members and statistical programming management, and completes project programming activities within timeframe allotted, Acts as the lead statistical programmer Directs the programming activities of other programming personnel and monitors progress on programming deliverables, Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities, Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor, Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process, Transfers deliverables, Performs other work-related duties as assigned, Minimal travel may be required Qualifications Should have an experience of 5+ years in Clinical Statistical programming with expertise in end-to-end programming (SDTM, ADAM & TLGs), Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience, Extensive programming experience in SAS or other required software, preferably in a clinical trial environment, Excellent written and verbal communication skills, Ability to read, write, speak and understand English, Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients, No matter what your role is, youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health, http://syneoshealth, Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above Further, nothing contained herein should be construed to create an employment contract Occasionally, required skills/experiences for jobs are expressed in brief terms Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job,

Description Medical Scientist Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities, Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for, Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives, Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program, We are committed to our Total Self culture where you can authentically be yourself Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people, We are continuously building the company we all want to work for and our customers want to work with WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives were able to create a place where everyone feels like they belong, Job Responsibilities Works with Medical Director to develop medical plans (Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan) Engages with outside experts/consultants/advisors to coordinate the acquisition of necessary medical/scientific input to prepare the respective medical plans, Performs regular and ad-hoc medical review of data listings and data visualization as needed; analyzes the data to identify risks and data patterns/trends and supports documentation of medical reviews, Authors medical data queries and reviews query responses, approves query closure in association with Medical Director, May assist Medical Director in patient profiles review, scientific review of other study level data, protocol deviation review, creation of Medical Review Summary report as needed, Partners with Medical Directors for medical data review meetings and safety review meetings including slide preparation as needed, Manages project scope of work, objectives, and quality of deliverables to ensure the project specific milestones and timelines are met Serves as primary interface between internal team, customers, and vendors in the areas of medical data review and eligibility review, Collaborates with study team members including Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management (set-up and/or lead meetings as appropriate) to identify risks related to data integrity and subject safety Escalates ongoing and newly developed study concerns such as at-risk project deliverables and out of-scope tasks to the project leads in a timely manner, Attends at Trusted Process meetings and may participate in internal and external audits, Acquires basic understanding and knowledge of ongoing protocol designs and disease related terminology and pathology, Adheres to all data privacy guidelines, International Committee on Harmonization (ICH), and Good Clinical Practices (GCPs), all enterprise policies, standard operating procedures, work instructions, and project plans Adheres to customer policies and standard operating procedures, as required in project plans, Qualifications Degree in life sciences (MSc, PharmD, PhD, DMD, MD) or equivalent with relevant scientific experience and/or training discipline, Excellent time management skills to handle multiple tasks and meet deadlines while delivering high quality work in a highly regulated and dynamic environment is essential, A self-starter and comfortable with fluctuating timelines, work demands and changes in scope of work, Ability to troubleshoot situations as needed and understands when issues or questions need to be escalated to the leadership, Understanding of scientific principles to assure effective and high-quality medical data analysis, Excellent written and oral communication skills, Excellent computer skills: MS Office programs, spread sheets, presentations, Prefer knowledge of drug development and demonstrated proficiency with ICH/GCP guidelines, Strong team player with excellent interpersonal skills and ability to work effective in a cross-functional team environment, Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients, No matter what your role is, youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health, http://syneoshealth, Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above Further, nothing contained herein should be construed to create an employment contract Occasionally, required skills/experiences for jobs are expressed in brief terms Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job,

Description Sr Medical Editor (Regulatory) Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities, Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for, Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives, Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program, We are committed to our Total Self culture where you can authentically be yourself Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people, We are continuously building the company we all want to work for and our customers want to work with WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives were able to create a place where everyone feels like they belong, Job Responsibilities Maintains familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance, Represents the editorial group in Medical Writing, on study teams, and in cross-departmental project teams as needed, Monitors timelines and budgets for assigned projects and updates the Lead Medical Writer, Project Manager, and/or direct supervisor (as appropriate) if deliverables are at risk, Provides technical support and expertise as appropriate Conducts training of medical editing staff and functions as a mentor Advises medical writers, medical editors, and study teams on data integrity review, compilation, publishing, and editorial standards Provides training to members of the global Medical Writing team in aspects relative to their roles, Project lead for deliverables of assigned complex and/or large medical writing projects, including but not limited to scheduling and leading internal project-specific team meetings, organizing project-specific requirements, and ensuring that all information is distributed to the editorial team and implemented within the deliverable, Serves as a member of the medical writing team for projects with medical writing deliverables Provides feedback to the lead medical writer on progress of document editorial process, Copyedits assigned documents, applying correct grammar, punctuation, spelling, and style following American Medical Association (AMA) or various custom style guidelines as well as established medical writing internal checklists and best practices, Performs data integrity review of assigned documents to ensure accuracy, Contributes to the development of process improvement tools and the development or revision of internal policies and procedures affecting editorial work, Manages assigned projects according to medical writing standard operating procedures and client standards, on time and on budget, May compile and publish medical writing deliverables, Qualifications Bachelors degree (preferred) in the life sciences, clinical sciences, or English/journalism; or copyediting, data integrity review, and/or relevant publishing experience, Significant relevant publishing experience using Adobe Acrobat or other appropriate markup language preferred; ISIToolbox experience preferred, Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Excellent attention to detail, including strong copyediting, data integrity review, accuracy, problem solving, organizational, interpersonal, presentation, project management, and team-oriented skills, Excellent grammatical and communication skills, both written and oral, Extensive familiarity with the AMA style guide strongly preferred, Ability to work with minimal supervision on multiple assignments with set deadlines, Ability to work independently as well as part of a team and keep others informed of the progress and status of projects, Adaptable to changes in work duties, responsibilities, and requirements, Knowledge of FDA and EU requirements, ICH regulations and ISO standards as applicable to regulatory documents preferred, Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients, No matter what your role is, youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health, http://syneoshealth, Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above Further, nothing contained herein should be construed to create an employment contract Occasionally, required skills/experiences for jobs are expressed in brief terms Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job,

Description Regulatory / Sr Regulatory Associate (Module 1, regulatory submission) Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities, Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for, Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives, Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program, We are committed to our Total Self culture where you can authentically be yourself Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people, We are continuously building the company we all want to work for and our customers want to work with WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives were able to create a place where everyone feels like they belong, Qualifications Job Responsibilities Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients, No matter what your role is, youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health, http://syneoshealth, Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above Further, nothing contained herein should be construed to create an employment contract Occasionally, required skills/experiences for jobs are expressed in brief terms Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job,

Description Sr Biostatistician Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities, Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for, Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives, Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program, We are committed to our Total Self culture where you can authentically be yourself Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people, We are continuously building the company we all want to work for and our customers want to work with WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives were able to create a place where everyone feels like they belong, Job Responsibilities Provides support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR, Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures Collaborate with the sponsor, if required, May be responsible for the statistical aspects of the protocol, generation of randomization schedule, publications and input to the clinical study report, Coordinates the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high quality work Provides independent review of project work produced by other biostatisticians in the department, Creates or reviews programming specifications for analysis datasets, tables, listings, and figures, Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis, Conducts and participates in verification and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP and specifications, Implements company objectives, and create alternative solutions to address business and operational challenges, Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives This would include preparing in advance for internal meetings, contributing ideas, and demonstrating respect for opinions of others, Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines, Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met Identifies out of scope tasks and escalate to management, Provides statistical programming support as needed, May participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development and serving as an independent non-voting biostatistician, May lead projects involving integrated analyses, attend regulatory agency meetings or respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor, Follows applicable SOPs, WIs, and relevant regulatory guidelines (e-g ICH), Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs; ensuring inspection readiness, Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business, Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings, Coaches and mentors other Biostatistics staff, Performs other work-related duties as assigned, Minimal travel may be required, Qualifications Graduate degree in biostatistics or related discipline, Moderate experience in clinical trials or an equivalent combination of education and experience, Proficiency in programming, Ability to apply knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research and to effectively communicate statistical concepts, Experience across all statistical tasks required to support clinical trials during the lifecycle of the project, from protocol to CSR, Excellent written and verbal communication skills, Ability to read, write, speak, and understand English, Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients, No matter what your role is, youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health, http://syneoshealth, Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above Further, nothing contained herein should be construed to create an employment contract Occasionally, required skills/experiences for jobs are expressed in brief terms Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job,

Description CRA II (Single Sponsor dedicated) Croatia Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities, Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for, Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives, Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program, We are committed to our Total Self culture where you can authentically be yourself Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people, We are continuously building the company we all want to work for and our customers want to work with WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives were able to create a place where everyone feels like they belong, Job Responsibilities Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes, Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate Demonstrates diligence in protecting the confidentiality of each subject/patient Assesses factors that might affect subject/patients safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues, Per the Clinical Monitoring/Site Management Plan (CMP/SMP): o Assesses site processes o Conducts Source Document Review of appropriate site source documents and medical records o Verifies required clinical data entered in the case report form (CRF) is accurate and complete o Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines o Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture o Verifies site compliance with electronic data capture requirements May perform investigational product (IP) inventory, reconciliation and reviews storage and security Verifies the IP has been dispensed and administered to subjects/patients according to the protocol Verifies issues or risks associated with blinded or randomized information related to IP Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned, Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness Reconciles contents of the ISF with the Trial MasterFile (TMF) Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations, Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan Supports subject/patient recruitment, retention and awareness strategies Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution, For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met Must be able to quickly adapt to changing priorities to achieve goals / targets, May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements, Prepares for and attends Investigator Meetings and/or sponsor face to face meetings Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements, Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions, Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required, For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II Additional responsibilities include: o Site support throughout the study lifecycle from site identification through close-out o Knowledge of local requirements for real world late phase study designs o Chart abstraction activities and data collection o Collaboration with Sponsor affiliates, medical science liaisons and local country staff o The SMA II may be requested to train junior staff o Identify and communicate out of scope activities to Lead CRA/Project Manager o Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations Qualifications Bachelors degree or RN in a related field or equivalent combination of education, training and experience Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements Must demonstrate good computer skills and be able to embrace new technologies Excellent communication, presentation and interpersonal skills Ability to manage required travel of up to 75% on a regular basis Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients, No matter what your role is, youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health, http://syneoshealth, Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above Further, nothing contained herein should be construed to create an employment contract Occasionally, required skills/experiences for jobs are expressed in brief terms Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job, Show more Show less

Description Medical Writer II (CSR Narrative exp Only) Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities, Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for, Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives, Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program, We are committed to our Total Self culture where you can authentically be yourself Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people, We are continuously building the company we all want to work for and our customers want to work with WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives were able to create a place where everyone feels like they belong, Job Responsibilities Mentors less experienced medical writers on projects, as necessary, Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision, Develops or supports a variety of documents that include but not limited to: o Clinical study protocols and clinical study protocol amendments; o Clinical study reports; o Patient narratives; o Annual reports; o Investigator brochures, Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency, Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables, Serves as peer reviewer on internal review team Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format, Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget, Performs on-line clinical literature searches, as applicable, Working knowledge of drug development process and regulatory guidelines, Continues professional development to keep pace with regulatory guidance and client expectations in medical writing that affect medical writing, Stays aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership, Completes required administrated tasks within the specified timeframes, Performs other work-related duties as assigned, Minimal travel may be required (less than 25%), Qualifications Min 3 years of medical writing experience and minimum 3yrs of relevant experience in Narrative writing Good Experience of independent authoring and reviewing CSR Narratives only, Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise, Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide, Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach, Strong proficiency in Word, Excel, PowerPoint, email, and Internet, Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information, Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients, No matter what your role is, youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health, http://syneoshealth, Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above Further, nothing contained herein should be construed to create an employment contract Occasionally, required skills/experiences for jobs are expressed in brief terms Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job,

Description Clinical Programmer II (Oracle PLSQL DBA) Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities, Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for, Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives, Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program, We are committed to our Total Self culture where you can authentically be yourself Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people, We are continuously building the company we all want to work for and our customers want to work with WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives were able to create a place where everyone feels like they belong, Job Responsibilities Good knowledge of RDBMS such as Oracle, PLSQL, Follow Client DBA processes Implement security measures to safeguard sensitive data and control user access, Troubleshoot DBA-related issues and provide resolution in a timely manner, Support team with database-related needs such as Data loads, schema changes, Implementations, Maintain data integrity, availability, and consistency across environments (development, test, production), Prepare documentation and technical reports, Qualifications Bachelors degree preferred, In lieu of Bachelors (Technical) degree, equivalent related education and experience, 0-3+ years of experience as a DBA or in a similar role, SAS, R Programming and Domino experience is an advantage, Proficiency in DBMS (e-g , Oracle, PLSQL), Strong knowledge of database structures, theories, principles, and practices, Familiarity with high availability (HA) and disaster recovery (DR) options, Strong analytical and problem-solving skills, Good to have knowledge of automation and scripting (e-g , PowerShell, Python, SAS, R Programming), The ability to deal effectively with sponsors and internal customers at all levels, Excellent communication and interpersonal skills, both written and spoken, with an ability to inform, Demonstrated experience in managing multiple priorities in a highly dynamic environment Experience working in a matrix-structured environment is preferred Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and Voicemail Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients, No matter what your role is, youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health, http://syneoshealth, Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above Further, nothing contained herein should be construed to create an employment contract Occasionally, required skills/experiences for jobs are expressed in brief terms Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job,

Description Pr Statistical Programmer(SDTM + ADAM + TLF) Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities, Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for, Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives, Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program, We are committed to our Total Self culture where you can authentically be yourself Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people, We are continuously building the company we all want to work for and our customers want to work with WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives were able to create a place where everyone feels like they belong, Job Responsibilities Uses SAS, or other software, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications, Works to ensure that outputs meet quality standards and project requirements, Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings, Keeps project team members informed of programming progress and issues requiring their attention, Follow applicable SOPs, WIs, and relevant regulatory guidelines (e-g ICH), Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness, Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload, Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework, Conducts effective internal meetings (appropriate in format, frequency and attendance) Distributes relevant information in advance Ensures minutes are promptly and accurately distributed Follows action items through to completion, and maintains order and focus of meetings, working toward consensus, Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business, Accountable for on-time delivery across concurrent programming deliverables Negotiates programming timelines and provides risk mitigation plans for projects or programs, as needed Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions, Acts as the lead statistical programmer Directs the programming activities of other programming personnel and monitors progress on programming deliverables, Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities, Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor, Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process, Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for complex programming questions, Works cooperatively with other biostatistics and statistical programming personnel to establish standardoperation procedures (SOPs), guidelines, policies, and/or procedures, Contributes technical expertise to the development of programming tools and macros for standardization and efficiency, When serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents (i-e DEFINE XML) When serving as a subject matter expert for CDISC and other industry and regulatory requirements, actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards, Transfers deliverables, Performs other work-related duties as assigned, Minimal travel may be required Qualifications Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience, Require 8+ years of experience in Clinical SAS Programming, Base SAS, Advance SAS, Must have strong experience in SDTM, ADAM & TLF for Safety & efficacy data both, Require eSub experience Must have study lead experience Excellent written and verbal communication skills, Ability to read, write, speak and understand English, Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients, No matter what your role is, youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health, http://syneoshealth, Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above Further, nothing contained herein should be construed to create an employment contract Occasionally, required skills/experiences for jobs are expressed in brief terms Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job, Show more Show less