Senior Medical Writer – Clinical Pharmacology (CSR, IB, Protocols)
Location: Remote – India | Job ID: 25104359 | Employment Type: Full-Time
About Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization dedicated to accelerating clinical development and improving patient outcomes. We combine clinical, medical affairs, and regulatory expertise to deliver innovative solutions tailored to modern healthcare and scientific challenges.
With 29,000 employees across 110 countries, we foster a collaborative, inclusive, and professional environment where innovation, scientific rigor, and patient focus drive every project.
Role Overview
The Senior Medical Writer – Clinical Pharmacology provides expertise in medical writing for clinical study documents, including Clinical Study Reports (CSRs), Investigator Brochures (IBs), study protocols, and amendments. This role ensures high-quality scientific writing, regulatory compliance, and effective communication with cross-functional teams and clients.
Key Responsibilities
Lead the preparation, review, and delivery of clinical pharmacology documents including CSRs, IBs, protocols, informed consents, safety reports, IND/NDA submissions, journal manuscripts, abstracts, posters, and presentations.
Ensure scientific accuracy, clarity, consistency, and adherence to ICH E3 guidelines, FDA/ICH regulations, and company/client SOPs.
Coordinate document quality, editorial review, and version control; serve as peer reviewer for internal team members.
Review statistical analysis plans, tables, figures, and listings, providing feedback to ensure clarity and appropriateness for document content.
Collaborate with clients, medical affairs, regulatory affairs, biostatistics, and data management teams to finalize documents.
Conduct literature searches and ensure compliance with copyright requirements.
Identify and resolve issues during the writing process, escalating as appropriate.
Mentor junior writers and provide guidance on complex medical writing projects.
Maintain awareness of project budgets and timelines, ensuring delivery within allocated resources.
Perform other work-related duties as assigned; minimal travel (<25%) may be required.
Qualifications & Experience
3–5 years of experience in scientific, medical, or technical writing within biopharmaceutical, medical device, or CRO environments.
Strong knowledge of FDA and ICH regulations, Good Publication Practices, and AMA style guide.
Proven experience writing CSRs, IBs, protocols, or related clinical documents.
Excellent command of English grammar, writing, and scientific communication skills.
Ability to collaborate with cross-functional teams, mentor junior staff, and deliver high-quality documentation on time and within budget.
Why Join Syneos Health
Work on critical clinical pharmacology documents that support global drug development.
Collaborate with multidisciplinary teams in a supportive and inclusive environment.
Contribute to projects that impact patient care and regulatory submissions worldwide.
Access continuous professional development, mentorship, and career progression opportunities.
Apply Now
Join Syneos Health as a Senior Medical Writer – Clinical Pharmacology and contribute to high-quality scientific communications that support global clinical research and regulatory excellence.
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