Job Title: Senior Medical Writer – Publication Writing
Location: India (Remote)
Job ID: 25104931
Employment Type: Full-Time
Industry: Clinical Research | Biopharmaceuticals | Medical Communications | CRO
Syneos Health is hiring an experienced Senior Medical Writer – Publication Writing to join its Clinical Development team in India (remote). This role is ideal for medical writing professionals with strong expertise in regulatory-compliant scientific documentation, journal manuscripts, and clinical study publications within the biopharmaceutical or CRO industry.
As a global biopharmaceutical solutions organization, Syneos Health partners with leading pharmaceutical, biotechnology, and medical device companies to accelerate therapy development and commercialization worldwide.
The Senior Medical Writer will lead and manage high-quality medical writing deliverables across clinical development programs, ensuring accuracy, regulatory compliance, and scientific clarity.
Lead the development and delivery of complex medical writing projects with minimal supervision.
Author and review publication-focused documents including:
Journal manuscripts
Abstracts and scientific posters
Conference presentations
Plain language summaries
Prepare regulatory documents such as:
Clinical Study Protocols and Amendments
Clinical Study Reports (CSRs)
Investigator Brochures (IBs)
Patient Narratives
Periodic Safety Update Reports (PSURs)
Clinical Development Plans
IND, NDA, and eCTD submissions
Integrated Summary of Safety (ISS) and Efficacy (ISE)
Ensure full compliance with:
ICH E3 guidelines
FDA regulations
Good Publication Practices (GPP)
Company and client SOPs
AMA Manual of Style
Review statistical analysis plans (SAPs), tables, figures, and listings (TFLs) to ensure alignment with reporting objectives.
Coordinate cross-functional collaboration with:
Biostatistics
Data Management
Regulatory Affairs
Medical Affairs
Conduct systematic literature searches and ensure proper citation and copyright compliance.
Lead internal and client document review cycles and resolve review comments.
Mentor junior medical writers and provide technical guidance.
Manage assigned projects within defined timelines and budget constraints.
Support health authority interactions through briefing books and response documents.
3–5 years of relevant experience in medical, scientific, or technical writing.
Proven experience in the biopharmaceutical, medical device, or CRO industry.
Demonstrated experience authoring regulatory and publication documents.
Strong working knowledge of:
FDA and ICH guidelines
Global regulatory submission standards
Good Publication Practices (GPP)
Experience preparing manuscripts for peer-reviewed journals.
Hands-on experience with regulatory submission documentation (IND/NDA/eCTD preferred).
Bachelor’s degree in Life Sciences, Pharmacy, Medicine, Biotechnology, or related field.
Advanced degree (Master’s, PhD, PharmD, MD) preferred but not mandatory.
Exceptional scientific writing and editing skills.
Advanced knowledge of English grammar and technical communication.
Strong familiarity with the AMA Manual of Style.
Excellent analytical and critical thinking skills.
Ability to interpret statistical outputs and translate complex data into clear narratives.
Strong stakeholder management and client communication skills.
Ability to work independently in a fully remote environment.
Strong project management and time management capabilities.
Fully remote role based in India.
Minimal travel required (less than 25%).
Collaborative global team environment.
Exposure to multi-therapeutic clinical development programs.
Syneos Health is a leading fully integrated biopharmaceutical solutions organization with operations in over 110 countries and 29,000+ employees globally. The company has contributed to the development of 94% of all novel FDA-approved drugs over the past five years and supports clinical research across thousands of global trial sites.
This opportunity is ideal for experienced Medical Writers, Regulatory Writers, Clinical Documentation Specialists, and Publication Experts seeking remote roles in India within global CRO environments.
If you are looking to advance your career in medical writing, regulatory documentation, and scientific publications within the pharmaceutical and biotech industry, this position offers strong growth potential and global exposure.
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