Senior Medical Writer (Csr, Ib, Protocol Drafting)

3–5 years years

not specified

India

10 Sept. 5, 2025

Job Description

Job Type: Remote Education: Bachelor’s degree in life sciences, medicine, or a related discipline 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

Position: Senior Medical Writer (CSR, IB, Protocol Drafting)

📍 Location: IND – Remote
🆔 Job ID: 25100336
📅 Last Updated: September 4, 2025

Company Overview: Syneos Health®

Syneos Health is a leading, fully integrated biopharmaceutical solutions organization built to accelerate customer success. The company supports clinical development, medical affairs, and commercial operations with a focus on bringing new therapies to market faster.
With over 29,000 employees across 110 countries, Syneos Health is dedicated to transforming modern healthcare through innovation and collaboration.

🔗 Learn more about Syneos Health

Why Join Syneos Health

Career growth through training and internal mobility
Inclusive culture: Be your Total Self at work
Global collaboration with diverse teams
Comprehensive benefits and recognition programs
Client impact: Supported 94% of FDA-approved drugs in the last 5 years

Key Responsibilities

📄 Document Development

Lead and author various clinical and regulatory documents, including:
- Clinical Study Protocols and Amendments
- Clinical Study Reports (CSRs)
- Investigator Brochures (IBs)
- IND/NDA/eCTD submissions
- Informed Consents, Plain Language Summaries
- Annual Reports, Periodic Safety Update Reports (PSURs)
- Journal Manuscripts, Abstracts, Posters, Presentations

🔍 Quality, Review & Compliance

Ensure documents meet regulatory and internal quality standards (ICH E3, SOPs, AMA style)
Coordinate peer and quality reviews
Review Statistical Analysis Plans (SAPs) and TFLs for accuracy, consistency, and clarity
Perform literature reviews and ensure compliance with copyright requirements

🤝 Cross-functional Collaboration

Liaise with internal teams including:
- Data Management
- Biostatistics
- Regulatory Affairs
- Medical Affairs
Build strong relationships with clients and internal stakeholders

👥 Leadership & Mentoring

Mentor and guide junior medical writers
Provide training and consultation to staff on writing practices
Lead resolution of client comments and feedback

💼 Project Oversight

Manage timelines and writing activities independently
Ensure deliverables are completed on time and within budget

Required Qualifications

🎓 Education

Bachelor’s degree in life sciences, medicine, or a related discipline
Graduate degree preferred

🧠 Experience

3–5 years of relevant experience in science/technical/medical writing
Experience in CRO, pharma, biotech, or medical device industry required
Proven experience with writing CSR, IB, protocols, and other regulatory documents

Required Skills

Strong knowledge of:
- FDA and ICH regulations
- Good Publication Practices (GPP)
Excellent command of English grammar and writing skills
Familiarity with AMA Manual of Style
High proficiency in Microsoft Office (Word, Excel, PowerPoint)
Excellent:
- Proofreading and editing
- Time and project management
- Interpersonal and communication skills
Strong understanding of clinical research principles and medical terminology

Role Summary (P22 Level)

As a P22-level Senior Medical Writer, you will:

Write, edit, and deliver high-quality medical documents
Analyze and summarize clinical data
Prepare scientific exhibits, systematic reviews, and literature summaries
Support regulatory agency interactions through briefing documents and responses
Own and lead writing projects from initiation to finalization

Impact & Contribution

Drive clarity and accuracy in medical writing deliverables
Ensure regulatory compliance and scientific integrity
Coordinate cross-functional activities within clinical projects
Contribute to ongoing improvement of writing processes and templates

Core Focus Areas

Lead completion of medical writing deliverables
Coordinate with cross-functional teams
Ensure adherence to regulatory standards
Perform editorial reviews and quality checks
Mentor and train junior writers
Maintain budget and timeline adherence

Additional Notes

Tasks and responsibilities may evolve over time at the company's discretion
Syneos Health complies with all applicable equal employment opportunity laws
Accommodations will be provided as needed under the ADA

Apply Now

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Job Description

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