Senior Medical Writer (Publication Writing)

Syneos Health

3-5 years

preferred by company

10 Feb. 11, 2026

Job Description

Job Type: Full Time 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

Senior Medical Writer – Publication Writing | Gurugram, India (Hybrid)

Location: Gurugram, Haryana, India
Work Model: Hybrid
Job Type: Full-Time
Experience Required: 3–5 Years in Medical Writing / Publication Writing
Industry: Biopharmaceutical / CRO / Clinical Research
Job ID: 25104931

About the Organization

Syneos Health® is a globally recognized, fully integrated biopharmaceutical solutions organization focused on accelerating clinical development and commercialization success. With more than 29,000 professionals across 110 countries, the organization delivers scientific, regulatory, and medical expertise to pharmaceutical, biotechnology, and medical device companies worldwide.

Over the past five years, Syneos Health has contributed to 94% of Novel FDA Approved Drugs and 95% of EMA Authorized Products, supporting over 200 studies across 73,000 sites globally.

Role Overview

The Senior Medical Writer – Publication Writing will lead the development of high-quality scientific and regulatory documents, with a strong focus on journal manuscripts, abstracts, posters, and scientific meeting presentations. This role requires 3–5 years of relevant experience in medical writing within the biopharmaceutical, device, or CRO industry.

The position involves managing complex writing projects, mentoring junior writers, coordinating cross-functional inputs, and ensuring compliance with global regulatory standards and publication best practices.

This is a hybrid role based in Gurugram, India.

Key Responsibilities

Scientific & Publication Writing

Lead development of manuscripts, abstracts, posters, and presentations for scientific congresses.
Author and review clinical study reports (CSRs), protocols, investigator brochures, integrated summaries, IND/NDA submissions, and other regulatory documents.
Prepare plain language summaries, periodic safety update reports, and clinical development plans.
Conduct systematic literature searches and synthesize scientific data for publication and regulatory submissions.

Regulatory & Compliance Alignment

Ensure adherence to ICH E3 guidelines, FDA regulations, Good Publication Practices (GPP), and company SOPs.
Follow approved templates, authorship standards, and AMA Manual of Style guidelines.
Review statistical analysis plans and tables/figures/listings for consistency and clarity.
Coordinate quality control and editorial reviews.

Cross-Functional Collaboration

Partner with biostatistics, regulatory affairs, medical affairs, and data management teams.
Lead document review meetings and resolve client comments efficiently.
Maintain professional working relationships with internal teams and external stakeholders.

Leadership & Project Management

Mentor and guide junior medical writers on complex projects.
Monitor project timelines and budgets, ensuring on-time and on-budget delivery.
Identify process improvements and contribute to internal capability development.
Provide technical support and training within the medical writing function.

Minimal travel may be required (less than 25%).

Required Qualifications

3–5 years of experience in medical writing, scientific writing, or publication writing.
Prior experience in the biopharmaceutical, medical device, or contract research organization (CRO) industry is required.
Demonstrated expertise in manuscript development and regulatory document preparation.
Strong knowledge of FDA, ICH guidelines, and global regulatory requirements.
Familiarity with Good Publication Practices (GPP) and AMA Manual of Style.
Excellent command of English grammar and scientific communication.
Ability to interpret and present complex clinical and statistical data.
Strong organizational, leadership, and mentoring capabilities.

Advanced degree in Life Sciences, Pharmacy, Medicine, or related discipline preferred.

Why Join This Organization

Work on high-impact regulatory and publication projects supporting globally approved therapies.
Collaborate with multidisciplinary experts across clinical development and regulatory functions.
Access career advancement, leadership development, and specialized scientific training.
Be part of a global organization that values diversity, innovation, and professional excellence.

Apply Now

Experienced medical writers specializing in publication writing and regulatory documentation are encouraged to apply through thepharmadaily.com and advance their career in global clinical research and medical communications.

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Senior Medical Writer (Publication Writing)

Job Description

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