Senior Medical Writer (CSR, IB, Protocol) – Syneos Health | Gurgaon, India
Job Summary
Syneos Health is hiring an experienced Senior Medical Writer to lead the preparation of high-quality clinical and regulatory documents, including Clinical Study Reports (CSR), Investigator Brochures (IB), and study protocols. This role requires 5+ years of experience in medical writing, in-depth knowledge of ICH E3 guidelines, and expertise in regulatory and scientific communications within the pharmaceutical or CRO industry.
Compensation: Not disclosed (competitive package offered).
Responsibilities
Prepare and lead the completion of clinical and regulatory documents (CSR, IB, protocols, amendments, IND submissions, NDA/eCTD documents).
Review and edit statistical analysis plans, tables, figures, and listings for accuracy and clarity.
Conduct literature searches, analyze data, and ensure compliance with copyright requirements.
Coordinate with biostatistics, regulatory affairs, and medical affairs teams for document finalization.
Peer review documents for scientific content, formatting, and consistency.
Adhere to ICH E3, FDA, EMA, and other global regulatory standards.
Mentor and support junior medical writers on complex projects.
Ensure quality, budget, and timeline adherence for all writing deliverables.
Prepare posters, abstracts, journal manuscripts, and presentations for scientific meetings.
Contribute to continuous process improvement in medical writing practices.
Required Skills & Qualifications
Bachelor’s degree in life sciences or related field (Master’s preferred).
5+ years of experience in medical, technical, or scientific writing within the biopharma or CRO industry.
Strong understanding of FDA, ICH regulations, and global regulatory writing standards.
Expertise in CSR, IB, protocols, and safety reports.
Proficiency with AMA Manual of Style and MS Office tools.
Excellent presentation, proofreading, and project management skills.
Ability to interpret and present clinical trial data effectively.
Perks & Benefits
Competitive and performance-driven compensation package.
Global exposure to high-impact regulatory submissions.
Career development with technical and therapeutic training.
Inclusive Total Self culture promoting diversity and authenticity.
Opportunity to work on FDA-approved drug submissions and EMA-authorized products.
Company Description
Syneos Health® is a global biopharmaceutical solutions leader with 29,000 employees across 110 countries. The company partners with pharma and biotech clients to deliver end-to-end clinical development, regulatory writing, and commercial solutions, helping to bring life-changing therapies to patients faster.
Work Mode: On-site | Location: Gurgaon, Haryana, India
Compensation Range: Not specified
Call-to-Action
Ready to take the lead on global clinical writing projects? Apply now to join Syneos Health and advance your career as a Senior Medical Writer.
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