Senior Medical Writer (Csr, Ib, Protocol Drafting)

Syneos Health

3–5 years years

not specified

Gurugram

10 Sept. 5, 2025

Job Description

Job Type: Hybrid Education: Bachelor's degree in life sciences, medical, or relevant field (Graduate degree preferred) Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title:

Senior Medical Writer (CSR, IB, Protocol Drafting)

Company:

Syneos Health®
📍 Location: IND-Gurugram (Hybrid)
🆔 Job ID: 25100336
📅 Last Updated: September 4, 2025

About Syneos Health

Syneos Health is a fully integrated biopharmaceutical solutions organization that partners with companies to bring therapies to market faster. With 29,000+ employees across 110 countries, Syneos focuses on delivering customer success through innovation and clinical development expertise.

🔗 Learn more: www.syneoshealth.com

Why Join Us?

Career growth and training opportunities
Supportive and inclusive work culture
Recognition programs and total rewards
"Total Self" culture – authentic self-expression encouraged
A company built to be the employer of choice

Job Summary

As a Senior Medical Writer, you will lead the preparation of clinical and regulatory documents such as CSRs, protocols, IBs, IND/NDA submissions, and more. You will ensure high-quality, scientifically accurate, and compliant documentation. You will coordinate across departments and mentor junior writers while contributing to process improvements and regulatory compliance.

Core Responsibilities

✍️ Medical Writing & Document Development

Lead and author key clinical/regulatory documents, including:
- Clinical Study Reports (CSRs)
- Investigator Brochures (IBs)
- Clinical Protocols and Amendments
- IND/NDA submissions
- Annual reports, PSURs, DSURs, informed consents
- Journal manuscripts, abstracts, posters, and presentations
Ensure scientific information is clearly and accurately presented
Follow ICH E3 guidelines, client SOPs, and style guides

🔍 Review & Quality Control

Conduct and coordinate quality and editorial reviews
Review statistical analysis plans (SAPs), TFLs (tables, figures, listings) for consistency and clarity
Peer review documents for scientific accuracy and formatting
Ensure source documentation and references are managed appropriately

🤝 Cross-functional Collaboration

Liaise with cross-functional stakeholders (Data Management, Biostatistics, Regulatory Affairs, Medical Affairs, etc.)
Build and maintain effective relationships with internal teams and clients
Participate in project team meetings and contribute to strategy discussions

📚 Research & Compliance

Perform online clinical literature searches
Ensure compliance with copyright and referencing standards
Stay up to date with regulatory requirements and best practices in medical writing

👥 Mentoring & Leadership

Mentor and support junior writers on complex documents
Provide training and technical guidance to team members
Lead resolution of client comments and revisions

💼 Project Management

Manage timelines, budgets, and quality of assigned writing projects
Handle multiple deliverables with minimal supervision

Qualifications & Requirements

🎓 Education

Bachelor's degree in life sciences, medical, or relevant field (Graduate degree preferred)

🧠 Experience

3–5 years of relevant experience in medical, technical, or scientific writing
Experience in CRO, pharmaceutical, biotech, or device industry required
Proven experience with CSR, protocol, IB, and regulatory submission documents

🛠️ Skills & Knowledge

Strong knowledge of FDA, ICH, GPP, and regulatory guidelines
Excellent understanding of clinical research and medical terminology
Proficient in Microsoft Office (Word, Excel, PowerPoint)
Familiar with AMA Manual of Style
Strong English grammar, communication, and presentation skills
High attention to detail, time management, and multitasking abilities

Key Competencies

Scientific and regulatory writing expertise
Stakeholder engagement and collaboration
Project ownership and proactive problem-solving
Leadership and mentoring
Adaptability in a dynamic, fast-paced environment

Impact & Contribution at P22 Level

This role contributes significantly to:

Regulatory compliance and submission readiness
Clarity and consistency in communication of scientific data
Client satisfaction and project efficiency
Development of internal writing capabilities and standards

Additional Information

Job responsibilities are subject to change at the company’s discretion
Syneos Health complies with global employment regulations and the Americans with Disabilities Act (ADA)
Reasonable accommodations will be made when appropriate

Application Process

🔹 Apply Now or
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Senior Medical Writer (Csr, Ib, Protocol Drafting)

Job Description

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