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Senior Medical Writer (Publication Writing)

Syneos Health
Syneos Health
3-5 years
Not Disclosed
India
10 Feb. 12, 2026
Job Description
Job Type: Remote 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) – Remote

Updated: February 10, 2026
Location: Remote (India)
Job ID: 25104931
Company: Syneos Health
Experience Required: 3–5 Years in Medical, Scientific, or Technical Writing

Job Overview

Syneos Health is a globally recognized biopharmaceutical solutions organization focused on accelerating clinical development and improving patient outcomes through integrated clinical, medical affairs, and commercial expertise. With operations across more than 110 countries, the organization delivers innovative healthcare solutions by placing patients and customers at the center of its clinical development model.

The Senior Medical Writer (Publication Writing) role is responsible for leading medical and scientific writing activities related to clinical research, regulatory documentation, and publication development. This position requires expertise in publication writing, clinical documentation, and regulatory standards, along with strong leadership and cross-functional collaboration capabilities.

This remote opportunity is ideal for experienced medical writers seeking to contribute to global clinical research and scientific communication initiatives within the biopharmaceutical or contract research industry.

Key Responsibilities

  • Lead the development and completion of medical writing deliverables, ensuring scientific accuracy, clarity, and regulatory compliance.

  • Manage medical writing activities across individual studies and coordinate deliverables across departments with minimal supervision.

  • Lead resolution of client feedback and comments on medical writing projects.

  • Develop and prepare a wide range of clinical and regulatory documents, including:

    • Clinical study protocols and amendments

    • Clinical study reports and patient narratives

    • Investigator brochures and informed consent documents

    • Annual reports and plain language summaries

    • Periodic safety update reports and clinical development plans

    • IND submissions, NDA submissions, and eCTD documentation

    • Integrated summary reports

    • Journal manuscripts, abstracts, posters, and presentations for scientific meetings

  • Ensure compliance with regulatory standards such as ICH E3 guidelines, company SOPs, client requirements, authorship standards, and publication guidelines.

  • Coordinate quality control and editorial review processes and manage source documentation.

  • Conduct peer review to ensure consistency, clarity, and quality of scientific documents.

  • Review statistical analysis plans and table, figure, and listing specifications for accuracy and completeness.

  • Collaborate with cross-functional teams including data management, biostatistics, regulatory affairs, and medical affairs.

  • Perform clinical literature searches and ensure compliance with copyright requirements.

  • Identify project challenges and propose effective solutions, escalating issues when required.

  • Provide technical support, mentoring, and training to junior medical writers.

  • Contribute to process improvements, internal standards, and capability development initiatives.

  • Manage project timelines, budgets, and deliverables effectively.

  • Complete administrative and project-related tasks within defined timelines.

  • Perform additional duties as assigned.

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

Eligibility Criteria and Qualifications

Education: Bachelor’s or postgraduate degree in Life Sciences, Pharmacy, Medicine, or a related scientific discipline preferred.

Experience:

  • Minimum 3–5 years of professional experience in medical, scientific, or technical writing.

  • Experience in publication writing and clinical documentation within the biopharmaceutical, medical device, or contract research organization (CRO) industry required.

Technical and Professional Requirements:

  • Strong understanding of FDA regulations, ICH guidelines, and global regulatory requirements.

  • Knowledge of Good Publication Practices and scientific publication standards.

  • Experience developing clinical and regulatory documentation.

  • Extensive knowledge of English grammar and scientific writing principles.

  • Familiarity with the AMA Manual of Style.

  • Strong project management and document review capabilities.

Core Competencies

  • Excellent written and verbal communication skills.

  • Strong analytical and problem-solving abilities.

  • Leadership and mentoring capabilities.

  • High attention to detail and quality standards.

  • Ability to manage multiple projects and meet deadlines.

  • Strong collaboration and stakeholder management skills.

Why Join Syneos Health

Syneos Health offers a collaborative and inclusive work environment focused on professional development, technical training, and career progression. The organization values diversity, innovation, and continuous learning while supporting advancements in global healthcare.

Over the past five years, Syneos Health has supported 94% of novel FDA-approved drugs, 95% of EMA-authorized products, and conducted more than 200 studies across 73,000 sites involving over 675,000 clinical trial participants.