Senior Medical Writer (Publication Writing) – Hybrid
Updated: February 10, 2026
Location: Gurugram, India (Hybrid)
Job ID: 25104931
Company: Syneos Health
Experience Required: 3–5 Years in Medical, Scientific, or Technical Writing
Job Overview
Syneos Health is a leading global 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 scientific and medical writing activities across clinical research and regulatory documentation, including publication development for scientific journals and conferences. The role requires expertise in regulatory guidelines, publication standards, and clinical research documentation, along with strong leadership and project management capabilities.
This position is ideal for experienced medical writers with expertise in publication writing, clinical documentation, and cross-functional collaboration within the biopharmaceutical or contract research industry.
Key Responsibilities
Lead and manage medical writing deliverables, ensuring clarity, scientific accuracy, and regulatory compliance.
Coordinate and manage medical writing activities across individual studies and cross-functional teams with minimal supervision.
Lead resolution of client comments and feedback on medical writing deliverables.
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 scientific presentations
Ensure adherence to regulatory standards including ICH E3 guidelines, company SOPs, client requirements, and publication standards.
Coordinate quality and editorial reviews and manage source documentation.
Conduct peer review of documents to ensure scientific consistency, clarity, and formatting standards.
Review statistical analysis plans and table, figure, and listing specifications for accuracy and completeness.
Collaborate with cross-functional stakeholders including data management, biostatistics, regulatory affairs, and medical affairs teams.
Perform clinical literature searches while ensuring compliance with copyright standards.
Identify challenges in writing projects and propose effective solutions.
Provide technical support, training, and mentorship to junior medical writers.
Contribute to process improvements, internal standards, and capability development initiatives.
Maintain awareness of project budgets, timelines, and deliverable requirements.
Complete administrative and project-related tasks within defined timelines.
Perform additional responsibilities 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 standards.
Knowledge of Good Publication Practices and scientific publication requirements.
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 global healthcare advancements.
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.
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