Syneos - Clinical and Corporate - Prod

Description Regulatory Associate 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 Essential Functions MS in science/healthcare field, or equivalent combination of education and experience. Above 2 yrs experience EU experience is ideal, ROW, US experience is also fine System- Veeva (ideal), Any DMS /RIMS (data management system) experience Strong Communication Skills (Written and verbal) Assists with preparation of product development documents including gap analyses and clinical development plans. Assists with preparation of regulatory submission documents including components of investigational new drug applications (INDs), new drug applications or new marketing applications (NDAs/MAAs), drug master files (DMFs), variations, renewals, marketing authorisation transfers (MATs) and other lifecycle maintenance activities, according to current government regulations and guidelines. Conducts regulatory research to identify regulatory precedents and to support the preparation of orphan drug designation requests. Performs quality checks on related documents. Assists with submissions of other regulatory documents and other regulatory research as needed. Assists clients, customers, or others with general information Gathers, compiles, analyzes, and reports information. Gathers information, searches files and records, and makes personal contacts to obtain specific information in order to prepare detailed reports and compose routine correspondence. 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 Under supervision, supports regulatory agency submissions, regulatory research, and product development. Responsibilities typically include the creation of submission documents to support investigational new drug applications (INDs), new drug applications or new marketing applications (NDAs/MAAs), drug master files (DMFs), variations, renewals, marketing authorisation transfers (MATs) and other lifecycle maintenance activities.

Description Principal Stat Programmer 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 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 definesall 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 programmingdeliverables. 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 standard operation 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. Extensive programming experience in SAS or other required software, preferably in a clinical trial environment as demonstrated by the ability to lead multiple complex and/or global projects with teams of statistical programmers. Knowledge and experience in the use of CDISC Standards for regulatory agency requirements. Experience in submissions to a regulatory agency preferred. Experience in mentoring others in clinical trial process and CDISC Standards. 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, 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.

Description Medical Writer II (CTT) 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 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 Minimum 3 years of experience in Clinical Trial Disclosure (CTD), Clinical Trial Transparency (CTT) and Regulatory Medical Writing. Preferred experience with results posting for regulatory bodies such as US FDA, ClinicalTrials.gov (ct.gov), EudraCT and national registries. 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, 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.

Description Regulatory Consultant (Sterile Experience) 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 Primary Experience in regulatory submissions for sterile drug products, including aseptic and terminal sterilization processes. Preparation and review of Module 3.2.P sections related to sterile manufacturing, microbial control, and container closure systems. Post approval variation experience is mandatory for EU market. Familiarity with EU Annex 1 requirements and its application in variation, renewal submissions. Supports in preparation and peer review of regulatory submissions including variations, renewals, and responses to queries. Handling post-approval changes related to sterile facilities, cleanroom classification, sterilization methods, and equipment upgrades. Preparation of regulatory assessments and submission strategies specific to sterile dosage forms. Reviews of media fill protocols, filter validation data, sterility assurance, and cleaning validation documentation for submission readiness. Provides regulatory support during inspections and audits related to sterile manufacturing. Change control assessments and preparation of regulatory impact summaries. Day-to-day execution of tasks in accordance with client SOPs and regulatory standards for high-quality global CMC dossiers. Collaboration with cross-functional teams including QA, QC (microbiology), validation, technical, analytical, and site functions for data collection and dossier preparation. Secondary: Acts as a point of contact for coordination of documentation across functional teams to meet submission timelines. Effective communication through email and calls with internal and client stakeholders for updates and clarifications. Supports and mentors junior team members depending on project needs. Hands-on experience with RIMS/Veeva Vault. Open to working in cross-cultural and virtual team settings. Qualifications Minimum 6 years of experience required for regulatory submissions for sterile drug products with Master’s degree in pharmaceutical sciences (preferred) or Master’s degree in other life sciences. Demonstrated experience in contributing to the preparation of regulatory submissions including, for example IND, PMA, NDA, MAA, and CTD, including electronic submissions. Excellent interpersonal / communication skills including excellent written and verbal communication skills. Excellent customer service skills, with the ability to work both as a team member and independently. Good quality management skills. Advanced skills in Microsoft Office Applications. Ability to interact with staff from multiple departments and offices to establish project standards. Good initiative, adaptability, and pro-activity. Strong analytical skills, good attention to detail. Ability to work concurrently on projects, each with specific instructions that may differ from project to project. Fluent in speaking, writing, and reading 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, 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.

Description Sr Regulatory Consultant (Biologics/Biosimilars) 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 Primary Skills required Responsible for authoring and review of CMC sections of regulatory submissions, including Modules 2 and 3, for INDs, IMPDs, CTAs, BLAs, and MAAs, as well as briefing packages and health authority responses. Developing, reviewing, and ensuring the completeness of CMC sections within IND and IMPD applications. Ensure all documents are authored in accordance with regulatory guidance (FDA, EMA, ICH). Good understanding of analytical method development, validation, comparability and biosimilarity assessments, upstream and downstream process development. Provide peer review and mentorship to junior writers or team members, ensuring consistency and scientific accuracy across deliverables. Experience with post-approval changes, tech transfers, and product lifecycle management. Excellent written communication, scientific writing, and document organization skills. Stay current with evolving regulatory expectations and industry best practices related to CMC submissions for biologics and biosimilars. Secondary Skills required Deep understanding of CMC regulatory requirements for biologics/biosimilars, including ICH and region-specific guidance. Experience with biosimilars, monoclonal antibodies, recombinant proteins, or other biologics. Qualifications Minimum 8 years of experience required for CMC-Biologics along with Master’s degree in pharmaceutical sciences (preferred) or Master’s degree in other life sciences. Ability to work independently and manage multiple priorities in a fast-paced consulting environment. Detail-oriented, strong organizational skills to manage multiple priorities in a deadline-driven environment Experience with RIMS/Veeva Vault for submission management, document lifecycle tracking, and regulatory compliance 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.

Description Sr Regulatory Associate (CMC) 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 Primary: Practical understanding of ICH guidelines, GMP requirements, and regional regulatory frameworks (e.g., FDA, EMA) Post approval variation experience is mandatory for EU market and Preapproval MAA dosier experience for ROW is preferred. Strong experience in preparation, compilation, review and submission of high-quality CMC dossiers for variations, renewals, annual reports, RTQs. Can support change control assessment and impact assessments for global markets. Capable to execute day-to-day tasks according to client processes and SOPs for building high quality global CMC dossiers. Assists in training and mentoring of team members depending upon project requirements Preparation, review and finalization of quality compliance reports, liaising with site, QA/ QP’s, CRAs and Client CMC team. Ability to liaise with cross-functional teams (Quality, Manufacturing, Analytical, etc.) to gather necessary technical data and ensure regulatory consistency for global submissions. Timely sensitization /escalation within team to maintain compliance and adherence to timelines. Secondary: Understands Regulatory requirements for Marketing Authorization dossier applications for ROW markets. Optional experience for tracking/ submission of regulatory/CMC commitments and update the databases Hands on experience of RIMS/VEEVA vault. Excellent written and verbal communication skills Open to working in Cross-Cultural/Virtual teams. Attends client meetings as needed with relevant inputs Good communication skills - clearly articulate through emails/ calls; provide accurate update on regulatory activities for assigned products in internal or Client meetings Qualifications Minimum 4 years of experience required in preparation, compilation, review and submission of high-quality CMC dossiers for variations with Master’s degree in pharmaceutical sciences (preferred) or Master’s degree in other life sciences. Ability to work independently and manage multiple priorities in a fast-paced consulting environment. Detail-oriented, strong organizational skills to manage multiple priorities in a deadline-driven environment Experience with RIMS/Veeva Vault for submission management, document lifecycle tracking, and regulatory compliance 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.

Description Regulatory Associate ( CMC) 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 Primary Understands current global regulatory guidelines (ICH, FDA, EMA, etc.) for post approval changes. Preparation of high-quality global CMC dossiers for variations, renewals, annual reports and other lifecycle maintenance activities including change control assessment, Response to Queries /follow up queries, according to current Health Agencies’ regulations and guidelines Ability to interpret client processes and SOPs for day-to-day execution tasks Supports in preparation, review and finalization of quality compliance reports (APQR – Annual product quality review) Supports in building ancillary or document request trackers. Liaise with different functions to arrange required documentation for global submissions Timely sensitization /escalation within team to maintain compliance and adherence to timelines. Secondary Understands Regulatory (of different regions like LATAM, APAC, ME, AF, China etc) requirements for Marketing Authorization dossier applications for ROW markets. Supports in tracking and submission of regulatory/CMC commitments and update the databases Experience of RIMS/VEEVA vault will be preferred. Open to working in Cross-Cultural/Virtual teams Good communication skills - clearly articulate through emails/ calls; provide accurate update on regulatory activities for assigned products in internal or Client meetings Good aptitude and attitude to learn Qualifications Minimum 1 years of experience required for preparation of high-quality global CMC dossiers for variations, renewals, annual reports and other lifecycle maintenance activities including change control assessment. Master’s degree in pharmaceutical sciences (preferred) or master’s degree in other life sciences. Post approval variation experience is mandatory for EU MARKET and pre-approval MAA dossier experience (for ROW) is preferred. Demonstrated experience in contributing to the preparation of regulatory submissions including, for example IND, PMA, NDA, MAA, and CTD, including electronic submissions. Excellent interpersonal / communication skills including excellent written and verbal communication skills. Excellent customer service skills, with the ability to work both as a team member and independently. Good quality management skills. Advanced skills in Microsoft Office Applications. Ability to interact with staff from multiple departments and offices to establish project standards. Good initiative, adaptability, and pro-activity. Strong analytical skills, good attention to detail. Ability to work concurrently on projects, each with specific instructions that may differ from project to project. Fluent in speaking, writing, and reading 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, 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 Under supervision, supports regulatory agency submissions, regulatory research, and product development. Responsibilities typically include working closely with RA team members, creation of submission documents to support the preparation, tracking, and submission of regulatory documentation across various global marketsfor new submissions, variations, renewals, marketing authorisation transfers (MATs) and other lifecycle maintenance activities. Also, exposure to tools like Veeva RIM or other regulatory systems.

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: o Use a data-driven approach to identifying areas of risk o Publish metrics and KPI’s o Set enterprise requirements for secure software development based on common cyber security frameworks such as NIST, Hitrust, CSF. SafeCode, OWASP etc o Contribute to enterprise security policies and standards. o Evolve Secure SDLC standards and processes o 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: o Promote DevSecOps solutions and culture o Establish secure code management practices o Improve automated CI/CD pipelines with appropriate security services o Automate enterprise security requirements into backlogs o Champion cloud application and platform security engineering practices. o Delivery enterprise security patterns for software engineering o Participate in Proof of Concepts with the software engineering organization . Educate and drive engagement of modern secure software principles within the organization by: o Being a strategic advisor in software security. o Being a transformation agent in promoting a modern security engineering mindset. o 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 SUMMARYThe 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.

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: o Use a data-driven approach to identifying areas of risk o Publish metrics and KPI’s o Set enterprise requirements for secure software development based on common cyber security frameworks such as NIST, Hitrust, CSF. SafeCode, OWASP etc o Contribute to enterprise security policies and standards. o Evolve Secure SDLC standards and processes o 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: o Promote DevSecOps solutions and culture o Establish secure code management practices o Improve automated CI/CD pipelines with appropriate security services o Automate enterprise security requirements into backlogs o Champion cloud application and platform security engineering practices. o Delivery enterprise security patterns for software engineering o Participate in Proof of Concepts with the software engineering organization . Educate and drive engagement of modern secure software principles within the organization by: o Being a strategic advisor in software security. o Being a transformation agent in promoting a modern security engineering mindset. o 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 SUMMARYThe 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.

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.

Description Principal Biostatistician 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 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.

Description Principal Biostatistician 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 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.

Description Sr Statistical Programmer 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 Develop and maintain programs to create analysis datasets, tables, and figures, ensuring accuracy and compliance with statistical standards Provide comprehensive statistical programming support for statisticians, clients, or business needs, including troubleshooting and resolving programming issues Source, organize, and interpret complex data sets, utilizing advanced coding techniques to ensure data integrity and usability Collaborate with statisticians and other stakeholders to understand project requirements and deliver high-quality statistical outputs Evaluate existing programming processes, identify areas for improvement, and implement revisions to enhance productivity and efficiency Contribute to the design, implementation, and delivery of processes, programs, and policies, leveraging in-depth knowledge and skills within the statistical programming discipline Direct the work of lower-level professionals, providing guidance and mentorship to ensure the successful completion of projects and tasks Manage processes and programs related to statistical programming, ensuring alignment with organizational goals and objectives Ensure effective communication and collaboration with cross-functional teams to meet the needs of statisticians, clients, or businesses Stay updated with the latest advancements in statistical programming and data analysis techniques, continuously improving skills and knowledge to deliver innovative solutions Qualifications: Advanced degree in Statistics, Computer Science, or a related field Proven experience in statistical programming and data analysis Strong knowledge of programming languages such as SAS, R, or Python Familiarity with data visualization tools and techniques Excellent problem-solving and analytical skills Ability to work independently and manage multiple projects simultaneously Certifications: SAS Certified Advanced Programmer for SAS 9 or equivalent certification Certification in data analysis or statistical programming is preferred Necessary Skills: Proficiency in statistical programming and data manipulation Strong understanding of statistical methodologies and data analysis techniques Ability to develop and implement efficient programming solutions Excellent communication and collaboration skills Attention to detail and commitment to quality Ability to adapt to changing project requirements and priorities 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 Roles within the Statistical Programming job family at the P22 level are responsible for developing programs and providing statistical programming support for statisticians or for client or business use. These roles address needs for sourcing, organizing, and interpreting complex data sets utilizing codes and programs. This includes developing codes that create analysis datasets, tables, and figures, evaluating programming processes, and suggesting revisions geared toward increasing productivity.Impact and ContributionRoles within the Statistical Programming job family at the P22 level contribute significantly to the design, implementation, and delivery of processes, programs, and policies. These roles involve in-depth knowledge and skills within a professional discipline, understanding the impact of work on related areas, and may be responsible for entire projects or processes within their area of responsibility. Individuals in these roles may direct the work of lower-level professionals or manage processes and programs, ensuring that statistical programming support is effectively provided to meet the needs of statisticians, clients, or businesses.Core Focus•Developing programs and codes to create analysis datasets, tables, and figures•Providing statistical programming support for statisticians or for client or business use•Sourcing, organizing, and interpreting complex data sets•Evaluating programming processes and suggesting revisions to increase productivity•Contributing to the design, implementation, and delivery of processes, programs, and policies•Directing the work of lower-level professionals or managing processes and programs•Ensuring effective statistical programming support to meet the needs of statisticians, clients, or businesses

Description Principal Statistical Programmer 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 Develop and maintain statistical programming standards and best practices Provide technical expertise and leadership in the development of statistical programs Collaborate with statisticians and other stakeholders to understand and address their programming needs Ensure the accuracy and integrity of data and statistical outputs Troubleshoot and resolve programming issues and challenges Mentor and train junior programmers and other team members Contribute to the continuous improvement of programming processes and tools Design and implement efficient programming solutions to meet project requirements Conduct code reviews and provide constructive feedback to ensure high-quality programming deliverables Stay updated with the latest advancements in statistical programming and incorporate relevant techniques into practice Qualifications Advanced degree in Statistics, Computer Science, or a related field Extensive experience in statistical programming, preferably in a clinical or pharmaceutical setting Proficiency in programming languages such as SAS, R, or Python Strong understanding of statistical methods and data analysis techniques Excellent problem-solving and analytical skills Ability to work independently and as part of a team Strong communication and interpersonal skills Certifications SAS Certified Advanced Programmer for SAS 9 or equivalent certification preferred Necessary Skills Expertise in statistical programming and data analysis Proficiency in programming languages such as SAS, R, or Python Strong understanding of statistical methods and data analysis techniques Excellent problem-solving and analytical skills Ability to work independently and as part of a team Strong communication and interpersonal skills 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 Roles within the Statistical Programming job family at the P23 level involve developing programs and providing statistical programming support for statisticians or for client or business use. This includes sourcing, organizing, and interpreting complex data sets by creating statistical tables, listings, and graphs. The role also involves developing codes to create analysis datasets, tables, and figures, evaluating programming processes, and suggesting revisions to increase productivity. As a leading expert individual contributor, the P23 level professional is viewed as a valuable resource by peers and works to achieve organizational, functional, and business targets with measurable impact on department results.Impact and ContributionRoles within the Statistical Programming job family at the P23 level manage or contribute to projects, programs, or processes that span multiple related areas. They have comprehensive knowledge and skills in their professional discipline and understand the impact of their work on related areas. Their contributions are crucial in designing, implementing, and delivering processes, programs, and policies. They may direct the work of lower-level professionals or manage processes and programs, spending the majority of their time contributing to the design, implementation, or delivery of processes, programs, and policies using knowledge and skills typically acquired through advanced education.Core Focus•Developing programs and providing statistical programming support for statisticians or for client or business use•Sourcing, organizing, and interpreting complex data sets by creating statistical tables, listings, and graphs•Developing codes to create analysis datasets, tables, and figures•Evaluating programming processes and suggesting revisions to increase productivity•Managing or contributing to projects, programs, or processes that span multiple related areas•Directing the work of lower-level professionals or managing processes and programs•Contributing to the design, implementation, or delivery of processes, programs, and policies using advanced knowledge and skills

Description Medical Writing II (CSR Narrative, QC review) 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 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, 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. 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 Medical Writer II (CSR Narrative exp Only)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 EVERYWHEREWhy Syneos HealthWe 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.

Description Medical Writer I (CTT) 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 JOB SUMMARY Serves as medical writer on clinical study or regulatory project teams. Assists in writing, editing, and coordinating content for clinical/regulatory documents with dependent staff roles to ensure satisfactory completion of all writing projects. JOB RESPONSIBILITIES Candidate with min 1year of experience of clinical Trial Disclosure or CTT Should have good experience protocol registration, result registration Should have experience with results posting for regulatory bodies. 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: Clinical study protocols and clinical study protocol amendments; Clinical study reports; Patient narratives; 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%). 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 SUMMARYServes as medical writer on clinical study or regulatory project teams. Assists in writing, editing, and coordinating content for clinical/regulatory documents with dependent staff roles to ensure satisfactory completion of all writing projects.

Description IMS Budget Specialist 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 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.

Description Regulatory Manager (CMC, EU & Japan/China) 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 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.

Description IMS Reporting Specialist 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 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 IMS Reporting Specialist I (IND- Office based- Hyderabad) The team member will be responsible & manage project closure activities related to investigator payments by reviewing internal site contracts vs oracle database vs MCTMSPrimary Skills - Good in Excel, Reporting, Data Reconciliation, Handling payment data, and good communication skillsExcel - intermediate to advance [VLOOKUP, sum, if, data validation, conditional formatting, pivot tables, finding duplicate values, concatenate, converting data from text to columns, formatting date and values]Experience: 1-3 years of relevant Industry exposure Primary Skills – •Good in Excel, •Reporting, •Data Reconciliation,•Handling payment data, •Good communication skillGood to Have:Experience with clinical research / analyst who has experience dealing with financial side of the business. Preferably focus on clinical research experience since business is more focused on clinical industry.Auditing ExperienceLocation: Office based - Hyderabad

Description Associate, QA (Mumbai Location) 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 JOB RESPONSIBILITIES General Profile Experience: 1 to 2 years in the Life Sciences industry Will be performing Quality Control (QC) of medical event data Excellent attention to detail and analytical skills Office-based role with mandatory visits to the client office in Mumbai Technical Skills: Proficient in Microsoft Excel Regulatory Knowledge: Familiar with ICH-GCP guidelines Strong understanding of medical terminologies Assists in the tracking of planned and scheduled audits in the enterprise quality management system Updates audit schedules and calendars as requested by management. Assists in gathering documentation required by auditors for audits and inspections (e.g. training records, organizational charts). Assists auditors in obtaining follow-up information during customer audits and regulatory inspections. Enters audit-related data into the enterprise quality management system. Maintains, files, and archives relevant Quality Assurance (QA) documentation. Supervision Normally receives detailed instructions on day-to-day work and detailed instructions on new assignments. Supervision Normally receives detailed instructions on day-to-day work and detailed instructions on new assignments. 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 Supports the auditing team in gathering documentation for audits and inspections and tracking the schedule of audits and inspections in the enterprise quality management system.