Medical Writer Ii (Narrative Writing)

Syneos Health

2-4 years

preferred by company

10 Feb. 5, 2026

Job Description

Job Type: Full Time 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

Medical Writer II – Narrative Writing (CSR Safety Narratives)

Updated: February 3, 2026
Location: Gurgaon, Haryana, India
Job ID: 25100333-OTHLOC-5206-2DH
Employment Type: Full-Time

About Syneos Health

Syneos Health® is a globally recognized, fully integrated biopharmaceutical solutions organization focused on accelerating customer success. By combining clinical development, medical affairs, and commercial expertise, Syneos Health delivers high-impact solutions that address evolving regulatory, scientific, and market needs.

With a patient-centric Clinical Development model, Syneos Health continuously improves processes to enhance quality, efficiency, and collaboration. With more than 29,000 professionals across 110+ countries, the organization is driven by a shared mission to advance therapies that improve and save lives.

Role Overview

The Medical Writer II – Narrative Writing role is primarily focused on the authoring and review of Clinical Study Report (CSR) safety narratives. This position supports clinical development programs by producing high-quality, compliant medical writing deliverables and collaborating closely with cross-functional teams in a regulated biopharmaceutical environment.

This role is well suited for early- to mid-career medical writers seeking to strengthen their expertise in narrative writing, regulatory documentation, and global clinical development.

Key Responsibilities

Author, edit, and finalize CSR safety narratives, including addressing reviewer and client comments
Compile and develop medical writing deliverables that clearly and accurately present clinical and scientific information
Prepare a range of regulatory and scientific documents, including:
- Clinical Study Reports (CSR)
- Patient narratives
- Clinical study protocols and amendments
- Investigator Brochures and Informed Consent Forms
- Annual Reports and Plain Language Summaries
- Periodic Safety Update Reports (PSUR)
- Journal manuscripts, abstracts, posters, and scientific presentations
Ensure compliance with regulatory requirements including ICH E3, FDA, EMA guidelines, company SOPs, and approved templates
Coordinate and support quality control and editorial review processes
Participate in document review cycles, resolve comments, and ensure timely document finalization
Act as a peer reviewer to ensure scientific accuracy, clarity, consistency, and proper formatting
Review statistical analysis plans and TFLs for content accuracy, grammar, and consistency
Collaborate effectively with biostatistics, data management, regulatory affairs, and clinical teams
Conduct clinical literature searches in accordance with copyright and publication standards
Identify and escalate document-related issues, proposing appropriate solutions
Support mentoring of junior medical writers as needed
Maintain awareness of project timelines, budgets, and administrative requirements

Required Qualifications & Experience

Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or a related discipline; Master’s degree preferred
Minimum 2–4 years of relevant experience in medical, scientific, or technical writing
Hands-on experience in CSR safety narrative writing is strongly preferred
Experience working within a biopharmaceutical company, CRO, or medical communications agency is desirable
Working knowledge of FDA, ICH, EMA regulations and Good Publication Practices
Familiarity with relevant document types used in clinical development
Strong command of English grammar and scientific writing; familiarity with the AMA Manual of Style

Essential Skills

Strong medical writing, editing, and proofreading capabilities
Ability to interpret and present clinical and safety data accurately
Effective collaboration and communication skills
Strong attention to detail and organizational abilities
Proficiency in MS Office applications
Ability to work independently with minimal to moderate supervision

Why Join Syneos Health

Opportunity to contribute to global clinical studies supporting FDA- and EMA-approved therapies
Structured career development, training, and mentoring programs
Inclusive and diverse workplace culture focused on professional growth
Exposure to large-scale clinical programs impacting patients worldwide

Over the past five years, Syneos Health has supported:

94% of all Novel FDA-approved drugs
95% of EMA-authorized products
200+ studies across 73,000 sites and 675,000+ clinical trial patients

Additional Information

The responsibilities listed above are not exhaustive and may evolve based on business needs. Equivalent education, skills, and experience will be considered. This job description does not constitute an employment contract. Syneos Health is an equal opportunity employer and is committed to providing reasonable accommodations in accordance with applicable laws.

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Medical Writer Ii (Narrative Writing)

Job Description

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