Job Title
Senior Medical Writer (CSR, IB, Protocol Drafting)
Updated: September 4, 2025
Location: IND-Gurugram-Hybrid
Job ID: 25100336
About Syneos Health
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We combine clinical, medical affairs, and commercial insights to deliver outcomes that address modern market realities.
29,000 employees across 110 countries.
Worked with 94% of all Novel FDA Approved Drugs in the past 5 years.
Supported 95% of EMA Authorized Products.
Conducted 200+ Studies across 73,000 Sites and 675,000+ Trial patients.
Our Culture:
Total Self culture – be authentic and thrive.
Focus on career development, progression, technical training, and peer recognition.
Diverse, inclusive, and collaborative environment.
Job Responsibilities
Lead and deliver high-quality medical writing outputs with clarity and scientific accuracy.
Manage medical writing activities for individual studies, coordinating across departments.
Prepare a wide range of documents:
Clinical study protocols, amendments, reports, patient narratives, annual reports
Investigator brochures (IB), informed consents, plain language summaries
Periodic safety update reports (PSURs), clinical development plans
IND submissions, integrated summaries, NDA and eCTD submissions
Journal manuscripts, abstracts, posters, and presentations for scientific meetings
Ensure compliance with ICH E3 guidelines, regulatory standards, SOPs, client standards, and formatting guides.
Coordinate quality checks and editorial reviews; manage source documentation.
Review statistical analysis plans (SAPs), tables/figures/listings for content, grammar, and consistency.
Collaborate with clients, data management, biostatistics, regulatory affairs, and medical affairs teams.
Conduct literature searches, ensuring copyright compliance.
Provide solutions to writing/technical issues, offer training, and consultation to teams.
Mentor junior writers on complex projects.
Develop expertise in regulatory and industry requirements.
Ensure project deliverables are within budget specifications.
Qualifications
Education:
Bachelor’s degree in a relevant discipline required.
Graduate degree preferred.
Experience:
3–5 years in scientific, technical, or medical writing.
Industry background in biopharma, devices, or CRO.
Experience with FDA, ICH, and regulatory document types.
Knowledge & Skills:
Deep understanding of clinical research principles, medical terminology, and regulatory requirements.
Strong command of English grammar and medical writing standards (AMA Manual of Style).
Proficiency in MS Office Suite.
Excellent proofreading, presentation, and interpersonal skills.
Strong project/time management abilities.
Core Focus Areas (P22 Level)
Completion of regulatory and scientific documents (CSR, IB, PSUR, NDA/eCTD submissions, etc.).
Coordination of cross-functional writing activities.
Reviewing and analyzing statistical outputs to prepare results-driven documents.
Preparing briefing books, response documents, and regulatory submissions.
Conducting systematic literature reviews and summarizing data.
Acting as peer reviewer for internal teams.
Mentoring junior writers and building subject matter expertise.
Additional Information
Responsibilities listed are not exhaustive; additional tasks may be assigned.
Equivalent skills, experience, or education may be considered.
Committed to Equal Opportunity Employment and compliance with global legislation.
Reasonable accommodations provided under ADA as needed.
How to Apply
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