Sr. Medical Writer Clinpharm (Csr, Ib, Protocol)

Syneos Health

3-5 years

preferred by company

India Pune

10 Feb. 4, 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

Senior Medical Writer – Clinical Pharmacology (CSR, IB, Protocols)

Updated: Yesterday
Location: Pune, Maharashtra, India
Job ID: 25104359
Employment Type: Full-Time

About Syneos Health

Syneos Health® is a global, fully integrated biopharmaceutical solutions organization dedicated to accelerating clinical development and commercialization. By combining clinical, medical affairs, and commercial expertise, Syneos Health supports sponsors in navigating complex regulatory landscapes and delivering innovative therapies to patients worldwide.

With operations across more than 110 countries, Syneos Health’s patient-centric Clinical Development model emphasizes quality, efficiency, and regulatory compliance at every stage of the drug development lifecycle.

Role Overview

The Senior Medical Writer – Clinical Pharmacology is responsible for leading the development of high-quality regulatory and clinical documents, including Clinical Study Reports (CSRs), Investigator’s Brochures (IBs), and clinical protocols. This role manages medical writing activities for individual studies, ensures scientific accuracy and regulatory compliance, and collaborates cross-functionally with biostatistics, data management, regulatory affairs, and clinical teams.

The position requires strong expertise in regulatory guidelines, clinical pharmacology content, and end-to-end medical writing processes for global submissions.

Key Responsibilities

Medical Writing and Scientific Leadership

Lead the planning, development, and completion of clinical and regulatory documents, ensuring clarity, scientific accuracy, and consistency of content.
Author and review a broad range of deliverables, including clinical study protocols and amendments, CSRs, patient narratives, investigator brochures, informed consent forms, plain language summaries, periodic safety update reports, and clinical development plans.
Support global regulatory submissions, including INDs, NDAs, eCTD submissions, and integrated summary reports.

Regulatory Compliance and Quality Oversight

Ensure all documents comply with applicable regulatory standards and guidelines, including ICH E3, FDA, EMA, and internal and client-specific SOPs, templates, and style guides.
Coordinate and lead quality control, editorial, and cross-functional review processes, addressing reviewer comments and driving timely resolution.
Act as a peer reviewer, evaluating documents for scientific accuracy, clarity, structure, formatting, and consistency.

Cross-Functional Collaboration

Review statistical analysis plans and tables, figures, and listings (TFLs) to ensure appropriate interpretation and alignment with document objectives.
Collaborate closely with data management, biostatistics, regulatory affairs, clinical operations, and medical affairs to deliver high-quality writing outputs.
Build and maintain effective working relationships with internal stakeholders and external clients.

Mentorship and Process Improvement

Mentor and guide junior medical writers on complex projects, providing technical and editorial feedback.
Contribute to the development and enhancement of internal writing processes, standards, templates, and training materials.
Maintain up-to-date knowledge of evolving regulatory requirements, clinical pharmacology trends, and medical writing best practices.

Project and Administrative Management

Manage assigned projects within defined timelines and budgets, proactively communicating status updates and risks to medical writing leadership.
Complete required administrative tasks accurately and within established timelines.
Perform additional responsibilities as assigned to support business needs.

Required Qualifications and Experience

Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or a related scientific discipline; advanced degree preferred.
3–5 years of professional experience in medical, scientific, or technical writing, preferably within a CRO, pharmaceutical, or biotechnology organization.
Demonstrated experience authoring CSRs, Investigator’s Brochures, and clinical protocols.
Strong working knowledge of FDA, EMA, and ICH regulatory guidelines, including ICH E3, and good publication practices.
Excellent command of written English, with advanced proficiency in grammar, clarity, and scientific communication.
Strong familiarity with the AMA Manual of Style and regulatory document formatting standards.

Why Join Syneos Health

Opportunity to work on studies supporting the majority of recent FDA- and EMA-approved therapies.
Structured career development, mentoring, and technical training programs.
Collaborative, inclusive, and globally connected work environment.
Exposure to complex, high-impact global regulatory submissions and clinical development programs.

Additional Information

This job description outlines core responsibilities but is not exhaustive. Syneos Health reserves the right to assign additional duties as business needs evolve. Equivalent combinations of education, skills, and experience may be considered. Employment practices comply with all applicable local and international employment regulations, including equal opportunity and reasonable accommodation requirements.

Role Summary

The Senior Medical Writer – Clinical Pharmacology plays a critical role in the development of regulatory-compliant clinical documents, supporting global drug development and submission activities. The position combines scientific expertise, regulatory knowledge, project leadership, and mentoring to ensure the delivery of high-quality medical writing outputs across complex clinical programs.

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Sr. Medical Writer Clinpharm (Csr, Ib, Protocol)

Job Description

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