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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 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 – Hybrid (Gurugram, India)

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

About Syneos Health

Syneos Health® is a leading global biopharmaceutical solutions organization dedicated to accelerating customer success across the drug development lifecycle. By integrating clinical development, medical affairs, and commercial expertise, Syneos Health delivers innovative solutions that address evolving healthcare and regulatory challenges.

With a global workforce of over 29,000 professionals across 110+ countries, Syneos Health operates with a patient-centric Clinical Development model, continuously improving processes to support both sponsors and employees in a dynamic, fast-paced environment.

Position Overview

Syneos Health is seeking a Senior Medical Writer to join its Clinical Development team in a hybrid role based in Gurugram, India. This position is ideal for experienced medical writing professionals who can independently manage complex regulatory and clinical documents while collaborating effectively with cross-functional global teams.

The Senior Medical Writer will lead the preparation of high-quality medical writing deliverables, ensure regulatory compliance, mentor junior writers, and contribute to scientific and operational excellence across clinical programs.

Key Responsibilities

  • Lead the planning, development, review, and finalization of medical writing deliverables with minimal supervision

  • Manage medical writing activities for assigned clinical studies, including coordination across departments and functions

  • Author, review, and finalize a wide range of documents, including but not limited to:

    • Clinical Study Protocols and Amendments

    • Clinical Study Reports (CSRs)

    • Patient Narratives

    • Investigator Brochures

    • Informed Consent Forms (ICFs)

    • Periodic Safety Update Reports (PSURs)

    • Plain Language Summaries

    • Clinical Development Plans

    • IND submissions

    • Integrated Summaries (ISS/ISE)

    • NDA and eCTD submissions

    • Journal manuscripts, abstracts, posters, and scientific presentations

  • Ensure compliance with ICH guidelines (including ICH E3), FDA regulations, internal SOPs, and client-specific standards

  • Coordinate and lead quality control, editorial, and peer review processes

  • Act as a scientific peer reviewer to ensure accuracy, clarity, consistency, and correct formatting

  • Review statistical analysis plans and tables, figures, and listings for content accuracy and alignment with document requirements

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

  • Perform clinical literature searches in compliance with copyright and publication standards

  • Proactively identify issues, propose solutions, and escalate risks when required

  • Provide technical guidance, mentoring, and training to junior medical writers

  • Contribute to process improvement initiatives, internal documentation, and training materials

  • Manage assigned projects within defined budgets and timelines, communicating status updates to leadership

  • Complete required administrative and compliance-related tasks within agreed timelines

  • Limited travel may be required (less than 25%)

Required Qualifications

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

  • Prior experience in a biopharmaceutical company, medical device organization, or Contract Research Organization (CRO)

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

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

  • Excellent written and verbal communication skills with advanced proficiency in English grammar

  • Strong familiarity with the AMA Manual of Style

  • Ability to manage multiple deliverables, work independently, and meet tight deadlines

Why Join Syneos Health

  • Work on programs supporting the majority of novel FDA-approved and EMA-authorized products

  • Exposure to global clinical trials and regulatory submissions

  • Strong emphasis on professional development, training, and career progression

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

  • Opportunity to collaborate with global experts in a highly competitive and evolving industry

Equal Opportunity Statement

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

About the Medical Writing Function

The Medical Writing team supports regulatory submissions, clinical documentation, and scientific communications across all stages of drug development. Senior Medical Writers play a critical role in transforming complex clinical and statistical data into clear, compliant, and impactful documents for regulatory authorities, healthcare professionals, and scientific audiences.