177 Medical Affairs Jobs

Establish product presence with stakeholders through scientific information exchange in oncology drugs in hard-to-treat cancers in metastatic pancreatic cancer, digestive cancers, brain tumors, hematologic cancers,leukemia, pediatric cancers etc. Required Candidate profile Pharm D/MD (Pharmacology)/ Pharm D industry medical affairs experience in oncology with exposure to Radio Onco/Medical Onco/Solid tumors/Neuro surgery.Industry Field working essential in Pharma.

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 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 - 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.

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.

Medical Writer II (Clinical Trial Transparency) 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 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.

Accounts Receivable Coordinator I Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life . Discover what our 29,000 employees, across 110 countries already know. WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we re able to create a place where everyone feels like they belong. Job Responsibilities Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life . Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health: We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we re able to create a place where everyone feels like they belong. Duties & Responsibilities: Prepare invoice package from consolidated monthly data file. This includes preparing pivot tables and compiling scanned image backup. Route prepared invoice packages to Project Managers for review and approval Generate pass through invoices in Oracle. Create invoice pdf package and save invoices, summary and backup scans to M drive. Email PDF invoice package to clients or send hard copies via Federal Express if originals are needed. Update the Billing Repository after invoices are created, costs are checked, and invoice number is added to the repository. Respond to invoice related questions from operations or clients. Generate investigator invoices in Oracle and send to client. Provide Billing supervisor with details of corrections which require a journal to be prepared, they could be for: Project to project recode Costs which cannot be recharged following PM approval Update the Billing Repository for the above changes. Process credits and rebills as required. Qualification: 1-3 years of experience in Accounts Receivable - invoice processing. Knowledge of invoice generation and credit memo processing. Strong written and verbal communication skills. Strong MS Excel skills. Any ERP system experience. Experience of working in a multi-currency environment. Good organizational skills. Ability to communicate well when working with colleagues/clients in other countries. Attention to detail and accuracy. Desirable: Experience of using Oracle ERP system. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Job Description: The Expense Report Auditor will join a team who service the expense reporting needs of Syneos Health. This position is responsible for applying Syneos Travel Policy, Client Travel Policies, and Business Conduct Standards while performing a variety of expense report and auditing functions. The majority of tasks will involve processing and auditing expense reports while promoting a customer service environment by responding effectively to employee inquiries in a prompt, accurate, and professional manner. Duties may include, but not limited to: Job Responsibilities: Payment Processing Run payment batches (e.g., PPR - Payment Process Request) Monitor payment statuses and resolve errors Validate payment files before transmission Payment Formats Understand seeded formats (e.g., NACHA, SEPA, ISO20022) Assist in testing and validating custom formats Reconciliation Support Help with bank statement uploads Match payments with bank transactions Issue Resolution Investigate payment rejections or failures Log and track issues using internal ticketing systems Review AP share mailbox for invoices and approval based upon assignment Review AP share mailbox for inquires based upon assignment and respond within 48 hours; urgent request within 24 hours to vendor and/or internal customer Ensures all types of payments (check, ACH, wires) are made in a timely manner and are corded in Oracle accounts payable system Ensures proper approvals are included on all payments to be processed Creates check runs, EFT and wire payment batches, including preliminary register Reviews printed checks for accuracy and signatures Investigation of aged creditor balances exceeding supplier payment terms and collection of credit balances owing Assists in month end closing preparing monthly accruals Maintains files and documentations thoroughly and accurately, in accordance with company policy and accepted accounting practices. Comply with process controls outlined in narratives to meet Sarbanes-Oxley internal controls objectives. Maintain Update SOP s and operating guidelines timely. Maintain Learning Logs Follow up on invoices under queries, on hold and pending with approvers Reviewing payment exceptions & on hold documents. Qualifications Prior Accounts Payable experience for 01 to 03 Years in Payment Processing Hands-on experience in query resolution and reconciliation Strong Excel skills - at least intermediate level Experience of working in a multi-currency environment Strong organizational skills Good communication skills Ability to communicate well when working with colleagues/clients in other countries Attention to detail and accuracy Desirable: Experience of using Oracle ERP system

Principal Biostatistician (Non-Clinical Statistician) Job Responsibilities o Collaborates with field experts in Research and Pre-Clinical Development to plan, execute and analyze relevant experiments independently, notably o design of experiments feasible under given lab conditions, o support of sample-size calculations and application for animal testing licenses, o randomization, o data transfer into appropriate stats software, o interpretation of results o Takes statistical responsibility for one or more standard experiments o Develops the statistical analysis plan for the experiments as appropriate, ensuring overall consistency within and between projects o Facilitates the overall organization and coordination of statistical activities for specific experiments and small projects o Leads virtual cross-functional sub-teams within NCS/SIS of DS&AI o Assumes responsibility for the production and accuracy of the statistical deliverables and interpretation of the results o Works independently at routine and complex statistical questions and tasks o Develops and implements standard processes for the analysis of routine experiments o Oversees and ensures accurate and timely delivery of statistical work outsourced to external providers

HRIS Analyst II 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 responsibilities: - Provide day-to-day support for Workday HCM,including modules such as Core HCM, Absence, Compensation, Recruiting, Onboarding and Talent. - Configure, maintain, and troubleshoot Workday Business Processes (BPs), including condition rules, routing, approvals, and step configuration. - Partner with HR stakeholders to evaluate BP effectiveness and recommend improvements that enhance employee and manager experience. - Participate in the design, configuration, testing, and deployment of Workday enhancements, releases, and new functionality. - Support system integrations between Workday and other platforms, including time tracking, benefits, payroll, and identity systems. - Collaborate with cross-functional teams to gather requirements, document functional specs, and implement system changes. - Troubleshoot and resolve system issues, escalating to Workday support or IT as needed. - Create and maintain calculated fields, condition rules, business processes, and security groups in Workday. - Develop and maintain custom Workday reports (advanced, matrix, composite, dashboards) to meet stakeholder needs. - Monitor data integrity through regular audits and partner with HR teams to ensure data accuracy and compliance. - Support user acceptance testing (UAT) by developing test plans, test cases, and documenting results. - Serve as a Workday subject matter expert and provide end-user support and training as needed. - Proactively identify system enhancements and participate in roadmap planning with HR and IT. - Assist with Workday semi-annual releases by reviewing release notes, assessing impacts, and coordinating testing and rollout. Qualifications Qualification Requirements: - B.A. or B.S. degree in Human Resources, Information Technology, Business Administration, or related field or equivalent experience. - 2 - 4 years of experience supporting Workday HCM, preferably in a multi-module environment. - Experience Handling Workday tickets. - Working knowledge of HR processes and practices, with a strong understanding of HR data and transactions. - Proficiency in Workday reporting and calculated fields is highly desired. - Strong analytical and problem-solving skills with the ability to translate business needs into technical solutions. - Excellent communication and interpersonal skills with the ability to collaborate across teams. - Ability to manage multiple tasks in a fast-paced, deadline-driven environment. - Strong Microsoft Excel skills required. - Experience with project work, including requirements gathering, testing, and implementation preferred. - Self-motivated with a proactive mindset and the ability to work independently or as part of a team. 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.

Sr Statistical Programmer Job Responsibilities 5-8 years of experience in SDTM / ADaM / TFls. Develop and validate SDTM/ ADaM data sets, TDLs. Support Safety & efficacy Analyses Contribute to E-submission - generating define.XML and ADRG / SDRG and leading clinical study Trails Uses SAS or other software to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. Works to ensure that outputs meet quality standards and project requirements. Performs validation programming and works with other Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings. Keeps project team members informed of programming progress and issues requiring their attention. Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness. Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. Develops specifications for datasets and outputs of any complexity according to statistical and sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others. Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus. Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. Negotiates and establishes accurate time estimates for completion of study programming activities with internalteam members and statistical programming management and completes project programming activities within timeframe allotted. Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables. Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities. Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor. Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process. Transfers deliverables. Performs other work-related dutiesas assigned. Minimal travel may be required Qualifications Graduate / Post Graduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience. Extensive programming experience in SAS or other required software, preferably in a clinical trial environment. Excellent written and verbal communication skills. Ability to read, write, speak and understand English.

Sr Statistical Programmer - SDTM, ADAM & TLFs Job Responsibilities Uses SAS or other software to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. Works to ensure that outputs meet quality standards and project requirements. Performs validation programming and works with other Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings. Keeps project team members informed of programming progress and issues requiring their attention. Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness. Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. Develops specifications for datasets and outputs of any complexity according to statistical and sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines allvariables to be accepted by peer review and sponsor/requestor with little rework. Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others. Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus. Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. Negotiates and establishes accurate time estimates for completion of study programming activities with internal team members and statistical programming management, and completes project programming activities within timeframe allotted. Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables. Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities. Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor. Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process. Transfers deliverables. Performs other work-related duties as assigned. Minimal travel may be required Qualifications Should have an experience of 5+ years in Clinical Statistical programming with expertise in end-to-end programming (SDTM, ADAM & TLGs). Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience. Extensive programming experience in SAS or other required software, preferably in a clinical trial environment. Excellent written and verbal communication skills. Ability to read, write, speak and understand English.

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

IMS Specialist II (Customer Support) 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 Processes investigator payments by: Maintaining the investigator payment portion of the IMPACT and Medidata System. Reviewing data with project manager for quality and completeness. Processing and creating approved grant payment requests via the IMPACT and Medidata system and forwarding or interfacing with A/P; and Distributing investigator payments to respective sites Creates, maintains, and reconciles MS Excel Project Grant Tracker as necessary. Reviews and interrogates Clinical Trial Agreements (CTAs) and CTA amendments to ensure payments are made according to the documented payment terms and schedule. Discrepancies should be escalated to their line manager or the appropriate project team member as needed. Communicates with site to secure invoices and resolve queries Communicates with IMS Lead and IMS 1 on resolution and processing of invoices Confident to communicate with sites in global locations both in writing and on the telephone Escalates to clinical team where appropriate to follow up on invoice discrepancies, past due invoices and to request refunds from sites. Ensures proper account and project coding are applied to third party invoices as it relates to investigator payments. Assists with customer audits of site payments and sponsor deposits. Trains and mentors less experienced staff members on departmental Standard Operating Procedures(SOPs), processes, tools, and templates. Minimal travel may be required(up to 25%). Works with sponsor systems and applications as required by the project. Qualifications BA/BS degree in Business, Accounting, or equivalent combination of education and experience. Proficiency in Microsoft Office Suite(Word, Excel, PowerPoint), email, and voicemail. Excellent written and verbal communication skills. Excellent English. Other foreign language proficiency preferred. Ability to organize and prioritize work to meet deadlines in a dynamic environment. Above average attention to detail, and interpersonal skills with a team-oriented approach. Oracle experience preferred but not mandatory. 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.

Principal Biostatistician Job Responsibilities

Principal Statistical Programmer 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

Pr Statistical Programmer(SDTM + ADAM + TLF) Job Responsibilities Uses SAS, or other software, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. Works to ensure that outputs meet quality standards and project requirements. Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings. Keeps project team members informed of programming progress and issues requiring their attention. Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness. Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus. Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. Accountable for on-time delivery across concurrent programming deliverables. Negotiates programming timelines and provides risk mitigation plans for projects or programs, as needed. Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions. Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables. Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities. Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor. Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process. Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for complex programming questions. Works cooperatively with other biostatistics and statistical programming personnel to establish standardoperation procedures (SOPs), guidelines, policies, and/or procedures. Contributes technical expertise to the development of programming tools and macros for standardization and efficiency. When serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents. (i.e. DEFINE.XML) When serving as a subject matter expert for CDISC and other industry and regulatory requirements, actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards. Transfers deliverables. Performs other work-related duties as assigned. Minimal travel may be required Qualifications Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience. Require 8+ years of experience in Clinical SAS Programming, Base SAS, Advance SAS. Must have strong experience in SDTM, ADAM & TLF for Safety & efficacy data both. Require eSub experience. Must have study lead experience Excellent written and verbal communication skills. Ability to read, write, speak and understand English.

Principal Stat Programmer - SDTM, ADAMs & TLFs- Consumer Health 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 - Must have more than 8 years experience in Clinical SAS programming - Must have good experience in SDTM, ADAM programming, specification creation, TLFs - Should have study lead experience of managing minimum 3 studies at a time. - eSub Experience - Define.xml Creation and Validation - Creation/Validation of SDRG/ADRG - Creation of eSub Packages to FDA - Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade Experience in mentoring others in clinical trial process and CDISC Standards.

Principal Stat Programmer(SDTM+ADAM+TLF) 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. Require 8+ years of experience in Clinical SAS Programming, Base SAS, Advance SAS. Must have strong experience in SDTM, ADAM & TLF for Safety & efficacy data both. Require eSub experience. Must have study lead experience Excellent written and verbal communication skills. Ability to read, write, speak and understand English. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, 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.

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position Patient Journey Partner Job Location: Kolkata, West Bengal We are seeking candidates to join our team as Patient Journey Partner In this role, you will have the opportunity to make a meaningful impact on patient care by connecting Roche capabilities and resources to co-create solutions with key stakeholders involved in the patient journey. Your role is multifaceted, addressing diverse patient journey needs such as accelerating access to treatments, streamlining decision making. This role is locally embedded in the ecosystem, it is an integrated role, functionally agnostic, (i.e. it does not fit into the traditional concepts of Commercial/Sales or Medical Affairs). The PJP focuses on the importance of bringing the outside in, working with partners to uncover all potential opportunities to transform outcomes for patients, faster. They also bring the inside out, to bring Roche expertise, science and knowledge to the ecosystem. Your Opportunity You will be responsible for end to end management of Top Therapy Area Expert relations and legitimate needs through right identification of challenges, belief, motivators You will be a one point of contact for top accounts of the state. You will be creating and executing strategies for the top public & private accounts, aligning with and support state teams for effective execution of the state strategies, so as to serve and maximize patients with Roche Innovations You will be building relationship with key decision makers in the account Identifying and resolving business issues in top accounts and Implement strategies and drive results for enhancing access to Roche innovations You will be leading collaboration in field through co-creation of solutions for key accounts Who you are You are someone who has a relevant graduate/ post graduate degree in Science with at least 2 years of experience in Oncology (solid tumor) You must exhibit strong collaboration and networking skills, process orientation and alliance management Experience of working in Apollo, TMC, NH, with medical oncologist will be preferred Who we are A healthier future drives us to innovate. Together, more than 100 000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let s build a healthier future, together. Roche is an Equal Opportunity Employer. "

ROLE SUMMARY: The medical director provides Clinical Development leadership and expertise on clinical trials, including overseeing the design, conduct, and analysis. The medical director works closely with other functions such as regulatory affairs, pharmacovigilance, biostatistics, and medical affairs to ensure that the clinical development program meets the scientific, ethical, and regulatory standards. The medical director also provides medical expertise and guidance to the clinical operations team, the investigators, and the external stakeholders such as health authorities, ethics committees, and patient advocacy groups. ROLE RESPONSIBILITIES: Study-level Clinical Development Leadership Collaborate with Clinical Scientist(s) to provide clinical leadership across 2-3 study team(s) that is scientifically rigorous and aligns with company objectives. Conduct medical monitoring activities including eligibility assessment, data review and safety monitoring. Lead peer-to-peer interactions with investigators. Serve as the point of contact for clinical issues between the study team, investigators, ethics committees, steering committees, and regulatory authorities. Lead and contribute to development and maintenance of clinical trial and regulatory documents, in collaboration with Clinical Scientist and the cross-functional team. Strategic Guidance, Clinical Insights & Interpretation Collaborate with Clinical Scientist to review and interpret clinical data, identify key findings and implications, and communicate to internal and external stakeholders. Maintains a high level of clinical expertise and professional competence by staying abreast of the latest developments, literature, and guidelines to advise on and drive current and future clinical development plans. QUALIFICATIONS: Medical degree (MD) Relevant clinical or industry experience considered 2-5 years industry experience Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Ability to travel to relevant international scientific congresses and internal team meetings 3-6 times per year Work Location Assignment: Hybrid Work Location Assignment: Hybrid At Pfizer we care about our colleagues wellbeing and offer a range of great benefits for them, including: Paid parental leave Access to Health & Wellness apps Career Growth Experiences program Recognition & rewards program Paid volunteer days Life Insurance Benefits Pfizer Learning Academy access to top content providers Access to flu vaccines & skin checks Options to purchase additional leave Salary packaging & novated lease options *Benefits listed may vary depending on your position and location and may be subject to change. Pfizer Australia and New Zealand s diverse workforce represents the patients we serve and the communities in which we operate. With a focus on Diversity, Equity & Inclusion (DE&I), Pfizer ANZ ensures our people are heard and cared for. We offer engagement opportunities in both Colleagues Resource Groups (CRGs) and workstreams across: Culture and Tradition, Reconciliation @ Pfizer (RAP), Gender Equity (GEN), Disability and through the Out Pfizer Employee Network (OPEN) for our LGBT + colleagues and allies. If you require reasonable adjustment during your application, please reach out to the Talent Acquisition Manager. Medical #LI-PFE

Medical Science Liaison - Womens Health Care ROLES AND RESPONSIBILITIES Primary Activities : Exchange and dissemination of scientific, educational, and research related information: The MSL plans, prepares and engages with Thought Leaders (TLs - Doctors) as an information scientist and colleague both proactively and reactively via various innovative TL engagements tactics and formats. MSLs provide dissemination, clarification and education of scientific data, study protocols, meeting abstracts, and professional literature (both proactive discussions on-label, and reactive discussions for unsolicited off-label questions in alignment with local regulations). Interactions with Medical Societies and Advisory Boards: The MSL answers medical / scientific queries of Medical Societies with regards to Bayer products and organizes / supports / participates in advisory boards. Participation at / networking in Congresses and Conventions: The MSL attends congresses and conventions, interacts with TLs (Doctors), establishes new contacts and gathers competitive intelligence. Coordination of Scientific Education Activities: The MSL plans and organizes scientific training and education events / sessions with TLs within their specific therapeutic area or product. TL identification / profiling / segmentation and strategy and engagement planning: In alignment with the product Medical Affairs plan, the MSL contributes to internal understanding of specific TL interests and expertise within the medical community at large. Preparation of reports and tracking activities: The MSL submits timely reports and tracks activities against agreed objectives Secondary Activities : External scientific support, training and education: The MSL provides additional external scientific support, training & education not covered by other primary activities. WHO YOU ARE: Qualification in natural sciences, or medical background (MD/ MBBS/BAMS/ BDS/ MDS) Basic knowledge of the area concerned with therapy (women s health, contraception, endometriosis) and related molecules Basic understanding of clinical trials, their design, and rationale. Ability to work independently as well as in a team environment and to build productive relationships both internally and externally Excellent presentation and written and verbal communication skills Bayer does not charge any fees whatsoever for recruitment process. Please do not entertain such demand for payment by any individuals / entities in connection with recruitment with any Bayer Group entity(ies) worldwide under any pretext. Please don t rely upon any unsolicited email from email addresses not ending with domain name bayer.com or job advertisements referring you to an email address that does not end with bayer.com Division: Pharmaceuticals Reference Code: 848287 Contact Us + 022-25311234

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position Patient Journey Partner Job Location: Kolkata, West Bengal We are seeking candidates to join our team as Patient Journey Partner In this role, you will have the opportunity to make a meaningful impact on patient care by connecting Roche capabilities and resources to co-create solutions with key stakeholders involved in the patient journey. Your role is multifaceted, addressing diverse patient journey needs such as accelerating access to treatments, streamlining decision making. This role is locally embedded in the ecosystem, it is an integrated role, functionally agnostic, (i.e. it does not fit into the traditional concepts of Commercial/Sales or Medical Affairs). The PJP focuses on the importance of bringing the outside in, working with partners to uncover all potential opportunities to transform outcomes for patients, faster. They also bring the inside out, to bring Roche expertise, science and knowledge to the ecosystem. Your Opportunity You will be responsible for end to end management of Top Therapy Area Expert relations and legitimate needs through right identification of challenges, belief, motivators You will be a one point of contact for top accounts of the state. You will be creating and executing strategies for the top public & private accounts, aligning with and support state teams for effective execution of the state strategies, so as to serve and maximize patients with Roche Innovations You will be building relationship with key decision makers in the account Identifying and resolving business issues in top accounts and Implement strategies and drive results for enhancing access to Roche innovations You will be leading collaboration in field through co-creation of solutions for key accounts Who you are You are someone who has a relevant graduate/ post graduate degree in Science with at least 2 years of experience in Oncology (solid tumor) You must exhibit strong collaboration and networking skills, process orientation and alliance management Experience of working in Apollo, TMC, NH, with medical oncologist will be preferred

Description. Sr Medical Writer (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 and leads less experienced medical writers on complex projects, as necessary.. Acts as lead for assigned writing projects.. Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. -Develops or supports a variety of documents that include, but not limited to:. Clinical study protocols and clinical protocol amendments;. Clinical study reports;. Patient narratives;. Clinical development plans;. IND submissions and annual reports;. Integrated summary reports;. NDA and (e)CTD submissions;. Investigator brochures, as well as;. Clinical journal manuscripts, clinical journal abstracts, and client presentations.. Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.. 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 providing review commentson draft and final documents.. 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.. Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.. Maintains awareness 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%). Trial transparency deliverables, protocol registration, protocol maintenance task, result posting for(CT.gov and EudraCT). Redaction of protocol and SAP (Statistical Analysis Plan). Qualifications. Minimum 7 years of experience in Medical Writing and atleast 5+ years of experience in Clinical Trial Transparency(CTT). 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.. Summary. Roles within the Medical Writing job family at the P22 level are responsible for writing and editing manuscripts and other medical communications on clinical studies and scientific reports. This includes special summaries from raw data for submission to regulatory agencies or for in-company use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication. The role involves screening, analyzing, and summarizing additional data from other sources as needed, conducting systematic literature searches and reviews, preparing literature for new products, and revising existing medical communication. These roles review and analyze statistical outputs to prepare results-based documents such as clinical study reports and development safety update reports. They support engagement and interaction with regulatory agencies through the preparation of briefing books and response documents to health authority questions. They may be responsible for entire projects or processes within their area of responsibility. Impact and Contribution Roles within the Medical Writing job family at the P22 level play a crucial role in ensuring the clear and accurate completion of medical writing deliverables, presenting scientific information clearly and accurately. They manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision. These roles lead the resolution of comments from clients and complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings. They adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides. These roles coordinate quality and editorial reviews, ensure source documentation is managed appropriately, and act as peer reviewers for the internal team to ensure document scientific content, clarity, overall consistency, and proper format. Core Focus. Leading the clear and accurate completion of medical writing deliverables. Managing medical writing activities associated with individual studies. Coordinating these activities within and across departments. Completing a variety of documents, adhering to established regulatory standards. Coordinating quality and editorial reviews. Acting as peer reviewers for the internal team. Reviewing statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency. Interacting and building good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs. Performing online clinical literature searches and complying with copyright requirements. Identifying and proposing solutions to resolve issues, providing technical support, training, and consultation to department and other company staff. Mentoring and leading less experienced medical writers on complex projects. Developing deep expertise on key topics in the industry and regulatory requirements. Working within budget specifications for assigned projects. Show more Show less

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.. Show more Show less

About The Job. Our Team:. Sanofi Global Hub (SGH) is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. SGH strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, Globally.. Main Responsibilities. The overall purpose and main responsibilities are listed below:. Create HEVA communications deliverables (including manuscripts, posters, abstracts, slide decks) aligned with HEVA strategy and global HEVA communication plan across relevant business units and product teams. Manage core HEVA communication processes, templates, and products across the portfolio in accordance with the scientific and value messages aligned with Core Value Dossier, the US AMCP Dossier, and HEVA contributions as appropriate to other submissions. Ensure Core Value Decks for key products are established and maintained, making available a regularly updated synthesis of critical HEVA evidence on the value of products. Maintain accountability for adherence to the publication standard operating procedure (SOP) and other compliance expectations relevant to HEVA communication processes. Seek opportunities to innovate HEVA value communications to increase the relevance and impact of HEVA evidence and inform optimal access and reimbursement decisions. Develop and maintain therapeutic area expertise. Coach junior HEVA writers and develop and review content created by them. Manage end to end process through iEnvision (previously, Datavision/Matrix). Collaborate effectively with stakeholders: HEVA, RWE, and Scientific communication global and/or local teams.. People: (1) Maintain effective relationships with the end stakeholders within the allocated GBU and product – with an end objective to develop education and communication content as per requirement for HEVA communications; (2) Interact effectively with healthcare professionals on publication content; and (3) Constantly assist other writers (junior) in developing knowledge and sharing learning. Performance: (1) Create HEVA communications deliverables (including manuscripts, posters, abstracts, and slide decks) aligned with HEVA strategy and global HEVA communication plan across relevant business units and product teams as per agreed timelines and quality; and (2) Provide strategic support with individuals and institutions, which may serve as resources for publications purpose, etc. Process: (1) Develop complex publications material; (2) Act as an expert in the field of medical communication for the assigned therapeutic area; (3) Assist the assigned scientific communication team in conducting comprehensive publication-needs analysis; (4) Manage core HEVA communication processes, templates, and products across the portfolio in accordance with the scientific and value messages aligned with Core Value Dossier, the US AMCP Dossier, and HEVA contributions as appropriate to other submissions; (5) Ensure Core Value Decks for key products are established and maintained, making available a regularly updated synthesis of critical HEVA evidence on the value of products; (6) Maintain accountability for adherence to the publication SOP and other compliance expectations relevant to HEVA communication processes; (7) Maintain accountability for adherence to the publication SOP and other compliance expectations relevant to HEVA communication processes; (8) Implement relevant element of publication plan and associated activities for the year identified for the region; (9) Work with selected vendors within the region to deliver the required deliverables as per defined process; and (10) Design an overall plan of action based on end-user feedback and improve course content and delivery. Stakeholder: (1) Work closely with HEVA global and local teams, RWE global and local teams and scientific communication teams in regions/areas to identify publications needs and assist in developing assigned deliverables; and (2) Liaise with HEVA global and local teams to prepare relevant and customized deliverables. About You. Experience: >4 years of experience in content creation for the pharmaceutical/healthcare industry, or academia. Soft skills: Stakeholder management; communication skills; and ability to work independently and within a team environment. Technical skills: Relevant training/experience in health economics, public health, epidemiology, or other relevant health-related scientific discipline (including but not limited to therapeutic area/domain knowledge exposure; knowledge of Good Publication Practice; publication submission; and/or project management). Education: Advanced degree in life sciences/pharmacy/similar discipline or medical degree. Languages: Excellent knowledge of English language (spoken and written). Pursue progress, discover extraordinary. Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!. null. Show more Show less

The Senior Medical Affairs Manager (MAM) is an experienced field-based member of the Medical Affairs team who serves as a strategic link between Alcon and Medical Experts (ME)/Key Opinion Leaders (KOLs) in the field of Ophthalmology and Optometry. The Senior MAM strategically supports the development and appropriate use/adoption of Alcon products and therapies through supporting evidence generation and evidence-based scientific exchange and by gathering actionable insights to further inform and shape the company's understanding of the products, therapeutic area, market access, and clinical practice. The Senior MAM responds to unsolicited requests for scientific exchange/insights, detailed working knowledge of FDA-approved Alcon products, current medical/scientific research, and publications and proposals for scientific research. The Senior MAM provides support for ECPs interested in participating in ALCON's Investigator Initiated Trials (IITs) by guiding them through the concept endorsement, synopsis review, and grant approval process, and acts as an end to end study liaison. The Senior MAM serves as a mentor to onboard new MAM and experienced team members in scientific subject matter and KOL/IIT management skills. The Senior MAM provides general medical/healthcare information by delivering unbiased scientific information (data dissemination) presentations to practitioners, third-party payors, and internal Alcon associates. The Senior MAM also responds to queries and unsolicited requests for medical information from doctors submitted to Medical Product Information and Complaint Handling and escalates to the MAM's team. The Senior MAM provides important information for making healthcare coverage and access decisions for Health Economics and Outcomes Research. Foster KOL/HCP interest in Investigator Initiated Trials (IITs) within Alcon's product strategy and liaise between potential researchers and Alcon on Investigator Initiated Trials (IITs) from inception to publication. Act as an interface between Medical Expert/HCP and Alcon to provide up-to-date medical support on device-related issues to educate, diagnose, resolve, and where applicable, escalate to local or regional Medical Affairs. Develop and maintain peer-to-peer scientific relationships with KOLs and decision-makers to expand evidence generation through scientific partnership opportunities; and gain their advocacy. Develop a strong understanding of the future needs of ophthalmic surgeons and support medical education in alignment with Alcon's strategy. Identify national, regional, and local KOL eye care provider experts according to their medical expertise and academic reputation. Liaise and provide up-to-date medical support to healthcare associations to ensure an evidence-based understanding of Alcon products relative to medical guidelines and medical evidence/health economic information. Assure thoughtful and informed exchange of current medical information and data related to Alcon products and selected areas of therapeutic interest with KOLs. Provides important information (HEOR/data) for payers making healthcare coverage and access decisions. Regularly collect, analyze, and report insights from the scientific exchange with ECPs that may impact company development plans/trial designs, launch, and brand strategies/tactics. Deliver effective presentations to ECPs and collect and report insights. Function as the Alcon medical speaker to present, as needed, at customer sites, ad board congresses, symposia, and training events for up-to-date data-based, scientific, and clinical information on Alcon product(s). Provide non-promotional speaker training to HCPs to support education/medical events to the healthcare community about therapies/devices developed and commercialized. Medical Support & Key Opinion Leader (KOL) Relationship Development Attend and provide scientific support for Medical Affairs activities and scientific sessions at regional and national congress meetings. Liaise and provide up-to-date medical support to healthcare associations to ensure an evidence-based understanding of Alcon products relative to medical guidelines and medical evidence/health economic information. Timely completion of all required training activities, documentation, and other administrative responsibilities. Deep scientific and KOL/IIT management skills that are used to coach and onboard new MAMs and team members Acts in lieu of a MAM Regional Director as a peer mentor, as a subject matter expert and possesses excellent operational excellence (time, budget/finance, data standards, reports etc) Internal Alcon Support Provide medical support and training, as appropriate, (i.e., disease state and product) to colleagues (e.g., sales reps, Regulatory Affairs colleagues, etc.), but not as a substitute for those functional training groups. Support educational efforts, such as wet lab activities, by proctoring such events and being onsite as necessary. Ensure cross-functional collaboration, and interface effectively with all other Medical Affairs functions, as well as other departments, including but not limited to Commercial, QA, Research and Development, Regulatory Affairs, and Market Access. Work with Med Info and Med Safety to help resolve escalated product complaints as well as Medical Safety issues. Comply with all credentialing requirements for any healthcare institution (e.g., hospital) that is part of the MAM's call plan, including, among other things, routine background checks, medical testing (i.e., Tuberculosis test) or proof of immunizations, training on facility policies, adherence to confidentiality, etc. Work with Integrity and Compliance observing all laws, industry standards, and company policies. Key Performance Indicators Number and quality of support for Investigator Initiated Trials, with documentation Key Performance Indicators (KPIs) for an associate in this role measuring progress and performance are aligned and set in accordance with: Organizational Objectives and Goals Departmental / Team Objectives and Goals Individual Objectives identified during the Performance Management Process Integrity and Compliance KOL Engagement and Relationship Management Quantity and quality of Investigator-Initiated Trials (IITs) submitted proposals in alignment with ALCON's Global Medical strategy Quantity and quality in the execution of Investigator-Initiated Trials (IITs) and other research project proposals received and successfully implemented Impact of the Research Proposals Quantity, quality, and content of monthly KOL interactions and presentations with scientific purpose Quantity and quality of support to KOLs presenting on Alcon products (e.g., Advisory Boards and other non-promotional meetings) Quantity and quality of new KOL relationships Ability to effectively address clinical questions and product complaints Quantity and quality of insights collected and reported from the scientific exchange with ECPs Quantity and quality of Identified KOLs who are qualified for Medical Affairs and R&D activities Quantity and quality of insights collected by the MAM at attended congresses, symposia, and training events Quantity and quality of podium presentations delivered at congresses, symposia, and training events Quantity and quality of SoV opportunities generated in the assigned territory Quantity and quality of events supported (such as presentations, webinars, focus groups, user meetings, advisory boards, symposia, customer training events) Training compliance report for the MAM MAM's Evaluation from internal stakeholders Contributions to educational materials, and impactful internal training presentations MAM's feedback from KOL and other HCP Level of collaboration and successful execution of integrated initiatives Quantity and Quality of Healthcare Economics presentations delivered internally and to payors Effectiveness and frequency of mentoring and training new MAMs, KOLs, and team members