Senior Medical Writer (Csr, Ib, Protocol Drafting)

Syneos Health

3-5 years

Not Disclosed

India Pune

10 Jan. 22, 2026

Job Description

Job Type: Full Time 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 – CSR, IB, Protocol Drafting

Location: Pune, Maharashtra, India
Job Type: Full-Time
Job ID: 25100336

About Syneos Health:
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We combine clinical, medical affairs, and commercial expertise to deliver innovative solutions that address modern market realities. With a global workforce of over 29,000 employees across 110 countries, we place the patient and customer at the center of everything we do.

Our mission is to simplify and streamline processes while fostering an environment that supports growth, inclusivity, and innovation.

Role Overview:
We are seeking a Senior Medical Writer to lead the creation, review, and delivery of high-quality medical writing deliverables for clinical studies. This role focuses on Clinical Study Reports (CSR), Investigator Brochures (IB), clinical study protocols, amendments, and other regulatory and scientific documents. You will collaborate with cross-functional teams, mentor junior writers, and ensure that all documents meet regulatory, client, and internal standards.

Key Responsibilities:

Lead and ensure the clear, accurate, and timely completion of medical writing deliverables.
Manage writing activities across individual studies, coordinating with cross-functional departments.
Develop, review, and finalize documents including:
- Clinical study protocols and amendments
- Clinical study reports (CSRs) and integrated summary reports
- Investigator brochures (IBs) and informed consent forms
- Periodic safety update reports (PSURs)
- Clinical development plans, IND, NDA, and eCTD submissions
- Journal manuscripts, abstracts, posters, and presentations
Adhere to regulatory guidelines, including ICH E3, and company SOPs, templates, and style guides.
Conduct peer review to ensure scientific accuracy, clarity, consistency, and formatting compliance.
Review statistical analysis plans and table/figure/listing specifications for accuracy and completeness.
Collaborate with clients, regulatory teams, biostatisticians, and data management teams to resolve queries.
Perform clinical literature searches and comply with copyright regulations.
Mentor junior writers on complex projects and provide technical support.
Maintain project deliverables within budget and timelines.

Required Skills and Qualifications:

Bachelor’s degree in a relevant scientific discipline; advanced degree preferred.
3–5 years of experience in medical writing within biopharmaceutical, CRO, or clinical research settings.
Strong knowledge of FDA and ICH regulations, Good Publication Practices (GPP), and regulatory submission standards.
Proven experience writing clinical study protocols, CSRs, IBs, and related documents.
Excellent command of English, grammar, and familiarity with AMA Manual of Style.
Strong project management, time management, and organizational skills.
Ability to collaborate effectively across cross-functional teams and mentor junior staff.
Proficiency in MS Office; familiarity with regulatory submission tools is a plus.

Why Join Syneos Health:

Opportunity to contribute to global clinical research impacting patient outcomes.
Exposure to diverse therapeutic areas and complex clinical studies.
Career growth through mentoring, training, and cross-functional collaboration.
Inclusive and engaging work environment with a focus on employee development.
Work with cutting-edge clinical development projects across multiple geographies.

Learn more about Syneos Health at syneoshealth.com.

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Senior Medical Writer (Csr, Ib, Protocol Drafting)

Job Description

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