Senior Medical Writer

5+ years

Not Disclosed

Gurugram

10 Oct. 19, 2025

Job Description

Job Type: Full Time Hybrid Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences 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

Updated: October 14, 2025
Location: IND – Gurugram (Hybrid)
Job ID: 25101484
Company: Syneos Health®

About Syneos Health®

Syneos Health® is a fully integrated biopharmaceutical solutions organization designed to accelerate customer success by combining clinical, medical affairs, and commercial expertise.

Our Clinical Development model places both the customer and patient at the center of everything we do. With over 29,000 employees across 110 countries, we continuously strive to simplify, innovate, and deliver therapies faster—because changing lives drives everything we do.

Motto: Work Here Matters Everywhere.

Why Work with Us

Continuous career development and progression opportunities.
Supportive and engaged line management.
Access to technical and therapeutic area training.
Peer recognition and total rewards program.
Commitment to our “Total Self” culture—be your authentic self.
A globally inclusive workplace that celebrates diversity of thought, culture, and perspective.

Job Summary

The Senior Medical Writer will lead and manage the preparation, writing, and review of various clinical and regulatory documents. The role requires strong scientific communication skills, deep understanding of clinical research principles, and the ability to coordinate writing activities across teams with minimal supervision.

Key Responsibilities

Leadership & Collaboration

Lead assigned writing projects and mentor less experienced medical writers.
Manage medical writing activities across multiple departments with minimal supervision.
Collaborate with cross-functional teams including Data Management, Biostatistics, Regulatory Affairs, and Medical Affairs.
Identify, troubleshoot, and propose solutions for challenges during the writing process.

Medical Writing Deliverables

Author, compile, and edit a range of documents including:
- Standard Operating Procedures (SOPs)
- Operating Guidance Documents
- Training Guides
- Clinical Study Protocols and Amendments
- Clinical Study Reports (CSRs)
- Investigator Brochures
- Patient Narratives
- Annual and Periodic Safety Reports
- Plain Language Summaries
- Regulatory submission documents (e.g., IND, NDA, eCTD)
- Journal manuscripts, abstracts, posters, and presentations

Process and Quality

Develop and update process maps and flowcharts (experience with MS Visio or similar tools preferred).
Review statistical analysis plans (SAPs), tables, figures, and listings for accuracy, consistency, and clarity.
Serve as peer reviewer to ensure quality, consistency, and scientific accuracy.
Ensure compliance with ICH-E3, FDA, and company/client-specific guidelines and templates.
Perform online literature searches and maintain compliance with copyright requirements.

Professional Standards

Maintain current knowledge of regulatory standards and evolving industry practices.
Work within project budgets and timelines; communicate deviations promptly.
Complete administrative responsibilities and required training on schedule.
Occasional travel (< 25%) may be required.

Qualifications

Education

Bachelor of Science (preferred in Life Sciences) with relevant writing experience,
OR
Bachelor of Arts (in English, Communications, or Social Sciences) with demonstrated scientific/medical knowledge.

Experience

Minimum 5 years of experience in medical writing.
Proven experience in end-to-end project management and document delivery.

Skills and Competencies

Strong command of English grammar and familiarity with AMA style guide.
In-depth understanding of FDA and ICH regulations.
Proficiency in Microsoft Word, Excel, PowerPoint, Email, and Internet tools.
Experience using MS Visio (or equivalent) for creating process maps.
Excellent presentation, editing, and leadership abilities.
Sound understanding of clinical research principles and ability to interpret clinical data.
Team-oriented approach with excellent interpersonal communication skills.

Role Summary (P22 Level)

Roles at the P22 level involve writing and editing scientific communications such as manuscripts, clinical study reports, and regulatory submissions. Responsibilities include:

Leading end-to-end completion of medical writing deliverables.
Coordinating medical writing activities across departments.
Managing quality and editorial review processes.
Conducting literature reviews and data interpretation.
Supporting regulatory interactions through briefing books and response documents.
Providing mentorship, technical consultation, and process improvement insights.

Core Focus Areas

Delivering accurate, clear, and regulatory-compliant medical documents.
Coordinating cross-departmental activities.
Managing and resolving client comments and feedback.
Maintaining consistency and compliance with authorship and formatting standards.
Acting as a peer reviewer to ensure scientific integrity.
Developing deep expertise in regulatory and therapeutic areas.

About Syneos Health’s Global Impact

Partnered in 94% of all FDA-approved novel drugs.
Supported 95% of EMA-authorized products in the last 5 years.
Conducted 200+ studies across 73,000 sites with over 675,000 trial participants.

Website: www.syneoshealth.com

Additional Information

Tasks and duties may be modified as required without prior notice.
Equivalent skills, experience, or education may be considered.
Complies with ADA and EU Equality Directives to support workplace accessibility and inclusivity.
This posting does not constitute an employment contract.

How to Apply

👉 Apply Now: Syneos Health Careers
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Senior Medical Writer

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