Senior Medical Writer – Regulatory Medical Writing
Updated: Yesterday
Location: Gurgaon, Haryana, India
Job ID: 25104299-OTHLOC-5206-2DH
Employment Type: Full-Time
About Syneos Health®
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success. By combining clinical development, medical affairs, and commercial expertise, Syneos Health delivers innovative, end-to-end solutions that address complex regulatory and market challenges across the global healthcare landscape.
With operations in over 110 countries, Syneos Health places patients at the center of its Clinical Development model and partners with sponsors through both Functional Service Provider (FSP) and Full-Service delivery models.
Position Overview
The Senior Medical Writer (Regulatory) is responsible for leading the development, review, and delivery of high-quality regulatory medical writing deliverables across clinical development programs. This role requires strong expertise in regulatory document authoring, deep knowledge of global regulatory guidelines, and the ability to manage medical writing activities independently while collaborating with cross-functional stakeholders.
The position plays a critical role in ensuring scientific accuracy, regulatory compliance, and timely delivery of documents supporting clinical trials and regulatory submissions.
Key Responsibilities
Regulatory Medical Writing and Leadership
Lead the preparation and completion of regulatory medical writing deliverables, ensuring clarity, scientific accuracy, consistency, and compliance
Independently manage medical writing activities for assigned studies with minimal supervision
Resolve client and internal review comments efficiently while maintaining document quality and timelines
Document Authoring and Review
Author and review a wide range of regulatory documents, including but not limited to:
Clinical Study Protocols and Protocol Amendments
Investigator’s Brochures and IB Updates
Clinical Study Reports (CSRs)
Informed Consent Forms (ICFs)
Development Safety Update Reports (DSURs) and DSUR Updates
Periodic Safety Reports
Patient Narratives
CTD Modules (including Modules 2 and 5)
IND, NDA, eCTD, and other regulatory submission documents
Plain Language Summaries, journal manuscripts, abstracts, posters, and scientific presentations
Quality, Compliance, and Collaboration
Ensure adherence to ICH guidelines (including ICH E3), FDA and EMA regulations, and applicable global regulatory standards
Follow company SOPs, client standards, approved templates, authorship requirements, and style guides
Coordinate internal quality control, editorial, and peer reviews; ensure appropriate source documentation management
Act as a peer reviewer to ensure scientific integrity, consistency, formatting, and overall document quality
Cross-Functional Interaction and Mentorship
Collaborate with Biostatistics, Data Management, Regulatory Affairs, Medical Affairs, and Clinical Operations teams
Review statistical analysis plans and tables/figures/listings for content accuracy, consistency, and clarity
Provide feedback to define statistical outputs and document requirements
Mentor and guide junior and mid-level medical writers on complex regulatory projects
Continuous Improvement and Administration
Conduct literature searches in compliance with copyright regulations
Identify risks and propose solutions, escalating issues when appropriate
Support internal training initiatives, process improvements, and development of internal materials
Track project budgets and timelines, communicating status updates to medical writing leadership
Complete administrative and compliance-related tasks within defined timelines
Minimal travel may be required (less than 25%)
Required Qualifications and Experience
Education
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Medicine, or a related scientific discipline (advanced degree preferred)
Experience
4–5 years of hands-on regulatory medical writing experience within the biopharmaceutical, biotechnology, medical device, or CRO industry
Demonstrated experience authoring core regulatory documents for global submissions
Skills and Knowledge
Strong understanding of FDA, EMA, and ICH regulatory requirements and global submission standards
Proven expertise with regulatory document types across clinical development and lifecycle management
Excellent command of written and spoken English with strong grammar and scientific communication skills
Thorough familiarity with the AMA Manual of Style
Strong organizational, analytical, and time-management skills
Ability to work independently while contributing effectively within cross-functional teams
Why Join Syneos Health?
Work on high-impact global regulatory submissions and clinical development programs
Collaborate with experienced medical, regulatory, and scientific professionals worldwide
Access ongoing career development, therapeutic area training, and leadership support
Be part of a diverse, inclusive, and innovation-driven organization
Over the past five years, Syneos Health has supported:
94% of novel FDA-approved drugs
95% of EMA-authorized products
200+ studies across 73,000 sites and more than 675,000 clinical trial participants
Additional Information
Job responsibilities may evolve based on business and project requirements
Equivalent combinations of education and experience will be considered
This job description does not constitute an employment contract
Syneos Health is an equal opportunity employer and complies with all applicable employment and accessibility regulations
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