Senior Medical Writer (CSR, IB, Protocol Drafting)
Updated: Yesterday
Location: Pune, Maharashtra, India
Job ID: 25100336
Employment Type: Full-Time
About the Company
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. By combining clinical, medical affairs, and commercial expertise, Syneos Health delivers outcomes that address today’s evolving healthcare and regulatory landscape.
With a patient-centric Clinical Development model, Syneos Health continuously works to simplify processes, foster innovation, and create a collaborative environment where employees can thrive while helping bring life-changing therapies to market.
With over 29,000 professionals across 110+ countries, Syneos Health offers a truly global platform where work has meaningful impact.
Position Overview
The Senior Medical Writer (CSR, IB, Protocol Drafting) is responsible for leading the development, review, and delivery of high-quality regulatory and clinical documents across multiple studies. This role requires strong scientific writing expertise, in-depth knowledge of global regulatory requirements, and the ability to mentor junior writers while managing complex deliverables with minimal supervision.
Key Responsibilities
Lead the preparation and finalization of clinical and regulatory documents, ensuring scientific accuracy, clarity, and regulatory compliance
Manage medical writing activities for assigned clinical studies, coordinating cross-functionally with data management, biostatistics, regulatory affairs, and medical affairs teams
Author and review a wide range of documents, including but not limited to:
Clinical Study Reports (CSR)
Investigator’s Brochures (IB)
Clinical study protocols and amendments
Patient narratives and informed consent forms
Plain Language Summaries (PLS)
Periodic Safety Update Reports (PSUR/DSUR)
Clinical Development Plans (CDP)
IND, NDA, eCTD, and integrated summary submissions
Journal manuscripts, abstracts, posters, and scientific presentations
Ensure adherence to ICH E3 guidelines, FDA and EMA regulations, company SOPs, client standards, and approved templates
Coordinate quality control, editorial, and internal review processes, addressing comments efficiently and accurately
Review statistical analysis plans (SAPs) and TFLs for scientific consistency and appropriate data presentation
Serve as a peer reviewer and subject matter expert within the medical writing team
Mentor and guide junior and mid-level medical writers on complex projects and regulatory strategies
Conduct clinical literature searches and ensure compliance with copyright and publication ethics
Identify risks, propose solutions, and provide technical guidance to internal stakeholders
Manage assigned projects within defined timelines and budget parameters
Maintain continuous professional development aligned with evolving regulatory and industry standards
Required Experience
3–5 years of hands-on experience in medical writing within the biopharmaceutical, CRO, or life sciences industry
Proven experience authoring CSRs, IBs, and clinical study protocols
Experience supporting regulatory submissions and interacting with cross-functional clinical teams
Educational Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or a related scientific discipline
Master’s degree or PhD preferred
Required Skills and Competencies
Strong understanding of FDA, EMA, ICH guidelines, and global regulatory frameworks
Excellent command of written English with strong knowledge of grammar and style
Familiarity with the AMA Manual of Style
Advanced understanding of clinical research principles and drug development processes
Strong project management, organizational, and time management skills
Proficiency in Microsoft Office applications
Ability to interpret, analyze, and present complex clinical and statistical data
Strong interpersonal, communication, and stakeholder management skills
Why Join Syneos Health
Exposure to global clinical programs and regulatory submissions
Career development through structured learning, mentorship, and progression opportunities
Collaborative and inclusive work culture driven by diversity and innovation
Opportunity to contribute to studies supporting the majority of FDA- and EMA-approved therapies
Over the past five years, Syneos Health has supported:
94% of all Novel FDA Approved Drugs
95% of EMA Authorized Products
200+ studies across 73,000+ sites and 675,000+ trial participants
Additional Information
This job description outlines the primary responsibilities of the role but is not exhaustive. Syneos Health reserves the right to assign additional duties as required. Equivalent education, skills, and experience may be considered. Employment is subject to local labor laws and equal opportunity regulations. Reasonable accommodations will be provided in accordance with applicable legislation.
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Mexico |northeastern :
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Brussels |Antwerp :
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Peru | Argentina |Brazil :
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Greece |North Island :
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Japan | Saitama |Tokyo :
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Warsaw |
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