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Senior Medical Writer

Syneos Health
Syneos Health
3-5 years
preferred by company
10 Jan. 28, 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 – Remote (India)

Location: India (Remote)
Employment Type: Full-Time
Job ID: 25104299
Industry: Clinical Research | Medical Writing | Biopharmaceuticals
Experience Required: 3–5 Years

About the Company

Syneos Health® is a globally recognized, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. With a strong presence across more than 110 countries and a workforce of over 29,000 professionals, Syneos Health combines clinical development, medical affairs, and commercial expertise to deliver meaningful outcomes for patients worldwide.

Guided by a patient-centric Clinical Development model, Syneos Health continuously streamlines processes to create value for sponsors while fostering an engaging and inclusive work environment for employees.

Role Overview

Syneos Health is seeking an experienced Senior Medical Writer to join its Clinical Development team in a remote capacity in India. This role is ideal for professionals with strong regulatory writing expertise who can independently manage complex medical writing deliverables across clinical trials, regulatory submissions, and scientific publications.

The Senior Medical Writer will lead document development, ensure regulatory compliance, collaborate cross-functionally, and mentor junior writers while maintaining high scientific and editorial standards.

Key Responsibilities

  • Lead the preparation, review, and finalization of high-quality medical writing deliverables with minimal supervision

  • Author and manage documents including but not limited to:

    • Clinical Study Protocols and Amendments

    • Clinical Study Reports (CSRs)

    • Patient Narratives

    • Investigator Brochures

    • Informed Consent Forms

    • Periodic Safety Update Reports (PSURs)

    • Integrated Summaries (ISS/ISE)

    • IND, NDA, and eCTD submissions

    • Clinical Development Plans

    • Plain Language Summaries

    • Journal manuscripts, abstracts, posters, and scientific presentations

  • Ensure compliance with global regulatory standards including ICH E3, FDA guidelines, and company SOPs

  • Coordinate internal and external quality, editorial, and peer reviews

  • Review statistical analysis plans and tables, figures, and listings for scientific accuracy and clarity

  • Resolve client comments efficiently and professionally

  • Collaborate with biostatistics, data management, regulatory affairs, and medical affairs teams

  • Conduct clinical literature searches in compliance with copyright standards

  • Mentor and provide technical guidance to junior medical writers

  • Identify process improvements and contribute to internal documentation and training materials

  • Manage assigned projects within approved budgets and timelines

  • Perform administrative and project tracking activities as required

  • Travel may be required on a limited basis (less than 25%)

Required Qualifications

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

  • Prior experience within a biopharmaceutical company, CRO, or medical device organization

  • Strong working knowledge of FDA regulations, ICH guidelines, and Good Publication Practices

  • Proven experience authoring regulatory and clinical documents across multiple study phases

  • Excellent command of English grammar, scientific writing, and document structuring

  • Strong familiarity with the AMA Manual of Style

  • Ability to manage multiple projects independently and meet tight deadlines

Why Join Syneos Health

  • Opportunity to work on studies supporting the majority of novel FDA-approved and EMA-authorized products

  • Exposure to global clinical programs and regulatory submissions

  • Strong focus on career development, training, and internal mobility

  • Inclusive “Total Self” culture that values diversity, equity, and authenticity

  • Competitive total rewards and professional growth opportunities

Equal Opportunity Statement

Syneos Health is committed to building a diverse and inclusive workplace. Qualified applicants will be considered without regard to race, gender, disability, or background. Equivalent experience and transferable skills will be considered. Reasonable accommodations will be provided in accordance with applicable laws.

About the Medical Writing Career Path

Roles within the Medical Writing function contribute to regulatory submissions, clinical documentation, and scientific communications supporting drug development and commercialization. Senior Medical Writers play a critical role in transforming complex clinical and statistical data into clear, compliant, and impactful documents for regulatory authorities and scientific audiences.