Senior Medical Writer

Syneos Health

3-5 years

Not Disclosed

Gurugram

10 Sept. 10, 2025

Job Description

Job Type: Hybrid Education: B.Sc/ M.Sc/ M.Pharm/ B.Pharm/ 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 Description – Senior Medical Writer (CSR, IB, Protocol Drafting)

About Syneos Health

At Syneos Health, our Clinical Development model puts the customer and patient at the center of everything we do. We continuously work to simplify and streamline processes—making it easier to work with us and for us.

With 29,000 employees across 110 countries, we collaborate with passionate problem solvers, leveraging agility and innovation to accelerate therapy delivery and improve lives.

Work Here Matters Everywhere.

Why Join Us

Career development and progression opportunities
Supportive, engaged line management
Technical and therapeutic training
Peer recognition and total rewards program
Commitment to Total Self culture—authenticity, inclusion, and belonging
Diversity of thoughts, backgrounds, and perspectives driving innovation

Position Overview

The Senior Medical Writer will be responsible for preparing, reviewing, and delivering high-quality medical writing documents in compliance with regulatory standards and client requirements. This role includes leading complex writing projects, mentoring junior writers, and collaborating across functions to ensure scientific accuracy and clarity.

Key Responsibilities

Lead the clear and accurate completion of medical writing deliverables
Manage writing activities for individual studies with minimal supervision
Draft, review, and finalize a wide range of documents, including:
- Clinical Study Protocols & Amendments
- Clinical Study Reports (CSR)
- Investigator Brochures (IB)
- Informed Consents & Plain Language Summaries
- Periodic Safety Update Reports (PSUR) & Annual Reports
- Clinical Development Plans & IND Submissions
- Integrated Summaries, NDA & eCTD Submissions
- Journal Manuscripts, Abstracts, Posters, & Presentations
Ensure compliance with:
- ICH E3 guidelines
- FDA/EMA and other regulatory standards
- Company/client SOPs, templates, and style guides
Review statistical analysis plans and outputs for accuracy and clarity
Act as a peer reviewer to ensure scientific content consistency and quality
Conduct literature searches and ensure copyright compliance
Mentor and guide junior medical writers on complex projects
Provide technical support, training, and consultation to peers and teams
Build strong working relationships with cross-functional teams (data management, biostatistics, regulatory, and medical affairs)
Manage writing projects within defined budgets and timelines

Qualifications

Bachelor’s degree in a relevant discipline (Master’s/PhD preferred)
3–5 years of relevant experience in medical, technical, or scientific writing
Experience in biopharmaceutical, medical device, or CRO industry required
Strong knowledge of FDA/ICH regulations and good publication practices
Proven experience writing relevant document types (CSR, IB, Protocols, etc.)
Strong command of English grammar and familiarity with AMA Manual of Style

Skills & Competencies

Excellent scientific writing, editing, and proofreading skills
Strong project and time management capabilities
Proficiency in MS Office applications
Solid understanding of clinical research principles and medical terminology
Ability to interpret and present complex clinical data clearly
Effective presentation, collaboration, and interpersonal skills

Impact & Contribution

As part of the Medical Writing (P22) job family, this role significantly contributes to:

Delivering regulatory-compliant, scientifically accurate documents
Supporting regulatory interactions through briefing books and response documents
Leading resolution of client feedback and ensuring document clarity
Enhancing team expertise and mentoring peers
Driving quality, compliance, and consistency in medical writing deliverables

Additional Information

Responsibilities listed are not exhaustive and may evolve with business needs
Equivalent combinations of education, experience, and skills will be considered
The company complies with all applicable employment legislation, including the EU Equality Directive and the Americans with Disabilities Act (ADA)
Reasonable accommodations will be provided where appropriate

About Syneos Health (Snapshot)

Worked with 94% of all Novel FDA Approved Drugs in the last 5 years
Supported 95% of EMA Authorized Products
Delivered over 200 studies across 73,000 sites with 675,000+ trial patients

Learn more: www.syneoshealth.com

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