Senior Medical Writer – Regulatory Medical Writing
Updated: Yesterday
Location: Pune, Maharashtra, India
Job ID: 25104299
Job Overview
Syneos Health® is a globally recognized, fully integrated biopharmaceutical solutions organization focused on accelerating the development and approval of innovative therapies. By integrating clinical development, medical affairs, and commercial expertise, Syneos Health delivers high-quality scientific and regulatory solutions across global markets.
We are seeking an experienced Senior Medical Writer with strong regulatory medical writing expertise to support clinical development and regulatory submission activities across multiple therapeutic areas.
Experience Required
Minimum 4–5 years of experience in regulatory medical writing
Prior experience within a pharmaceutical company, biotechnology firm, medical device organization, or CRO
Proven hands-on experience authoring regulatory and clinical documents for global submissions
Key Responsibilities
Regulatory & Clinical Writing
Lead the preparation, review, and finalization of regulatory and clinical documents, ensuring scientific accuracy, clarity, and regulatory compliance
Author and manage a wide range of documents, including but not limited to:
Clinical Study Protocols and Protocol Amendments
Investigator’s Brochures (IB) and IB Updates
Clinical Study Reports (CSRs)
Informed Consent Forms (ICFs)
Development Safety Update Reports (DSURs) and DSUR Updates
Periodic Safety Reports (PSURs)
CTD Modules and eCTD submission documents
Patient Narratives and Integrated Summary Reports
Project & Stakeholder Management
Manage medical writing deliverables for assigned studies with minimal supervision
Coordinate medical writing activities across cross-functional teams, including Biostatistics, Data Management, Regulatory Affairs, and Medical Affairs
Lead the resolution of internal and client review comments and ensure timely document finalization
Quality, Compliance & Review
Ensure adherence to ICH guidelines (including ICH E3), FDA and global regulatory requirements, SOPs, and approved templates
Coordinate editorial and quality control reviews to ensure consistency, accuracy, and inspection readiness
Act as a peer reviewer to assess scientific content, structure, formatting, and regulatory compliance
Review SAPs and TFL specifications to ensure alignment with document requirements
Scientific & Technical Expertise
Conduct clinical literature searches in compliance with copyright and citation standards
Maintain in-depth knowledge of regulatory guidelines, medical writing standards, and industry best practices
Develop subject matter expertise in assigned therapeutic areas and regulatory frameworks
Leadership & Mentorship
Mentor and guide junior medical writers on complex regulatory documents
Provide technical input, training, and process improvement recommendations
Support development of internal standards, tools, and training materials
Operational Responsibilities
Work within allocated project budgets and timelines, communicating status and risks to leadership
Complete required administrative and compliance tasks within defined timelines
Support additional medical writing activities as assigned
Minimal travel may be required (less than 25%)
Qualifications & Skills
Education
Bachelor’s or advanced degree in Life Sciences, Pharmacy, Medicine, or a related scientific discipline
Technical & Professional Skills
Strong understanding of FDA, EMA, and ICH regulatory requirements
Demonstrated expertise in regulatory document authoring and lifecycle submissions
Excellent command of English grammar and scientific writing, with strong familiarity with the AMA Manual of Style
Ability to analyze statistical outputs and translate data into high-quality regulatory documents
Strong organizational, communication, and stakeholder management skills
Ability to manage multiple projects in a fast-paced, regulated environment
Why Join Syneos Health
Opportunity to contribute to programs supporting 94% of novel FDA-approved drugs and 95% of EMA-authorized products
Exposure to global regulatory submissions and complex clinical development programs
Strong focus on professional growth, regulatory expertise, and leadership development
Inclusive and collaborative culture that values scientific excellence and diversity
About Syneos Health
Over the past five years, Syneos Health has supported more than 200 clinical studies across 73,000 sites, impacting 675,000+ clinical trial patients worldwide. With a workforce of 29,000+ professionals across 110 countries, Syneos Health continues to lead innovation in biopharmaceutical development.
Disclaimer
The responsibilities listed above are not exhaustive and may be modified based on business needs. Syneos Health reserves the right to determine equivalent qualifications and experience. This job posting does not constitute an employment contract. The company is committed to equal employment opportunity and compliance with applicable employment and accessibility regulations.
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