Job Title: Senior Medical Writer
Updated: October 14, 2025
Location: IND – Gurugram (Hybrid)
Job ID: 25101484
Company: Syneos Health®
About Syneos Health
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization committed to accelerating customer success. We transform clinical, medical, and commercial insights into real-world outcomes, uniting science and strategy to bring life-changing therapies to patients faster.
With over 29,000 employees in 110 countries, we are driven by innovation, collaboration, and purpose.
Work Here Matters Everywhere.
Why Join Us
Career Growth: Continuous learning, technical and therapeutic area training, and progression opportunities.
Supportive Leadership: Engaged line management, peer recognition, and total rewards programs.
Inclusive Culture: “Total Self” culture where you can authentically be yourself.
Global Impact: Partnered on 94% of FDA-approved novel drugs and 95% of EMA-authorized products over the past 5 years.
Core Responsibilities
Serve as lead writer for assigned medical writing projects with minimal supervision.
Manage end-to-end writing projects, ensuring timely and compliant delivery.
Mentor and guide less experienced medical writers on complex deliverables.
Compile, write, and edit a range of medical documents including:
Clinical Study Reports (CSRs)
Protocols and Amendments
Patient Narratives
Annual Reports and Investigator Brochures
SOPs, Operating Guidance Documents, and Training Guides
Develop process maps and flowcharts using MS Visio or similar tools.
Ensure documents meet regulatory, company, and client standards (ICH-E3, SOPs, templates).
Perform literature searches and maintain current knowledge of industry practices.
Review statistical analysis plans, tables, figures, and listings for accuracy and consistency.
Interact cross-functionally with data management, biostatistics, regulatory affairs, and medical affairs teams.
Serve as peer reviewer, ensuring scientific clarity, format consistency, and adherence to style guides.
Identify and propose solutions to resolve content or process issues during writing.
Maintain project budgets and timelines, communicating updates proactively.
Perform other duties as assigned; travel may be required (<25%).
Qualifications
Education:
Bachelor of Science (preferred) or Bachelor of Arts in English, Communications, or Social Sciences with relevant medical/scientific expertise.
Experience:
Minimum 5 years of experience in medical writing, preferably with experience managing full project cycles.
Strong knowledge of clinical research, drug development processes, and regulatory guidelines (FDA, ICH, AMA).
Skills:
Excellent written and verbal communication skills.
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
Expertise in process documentation and SOP creation.
Strong analytical and data interpretation abilities.
Proven leadership, mentoring, and project management skills.
Ability to work independently and collaboratively in cross-functional environments.
Role Summary
Senior Medical Writers at Syneos Health (P22 Level) are responsible for authoring, reviewing, and managing medical and scientific communications for clinical studies and regulatory submissions. This includes drafting and summarizing complex scientific data, ensuring accuracy, and maintaining regulatory compliance.
Key Focus Areas:
Lead and manage medical writing deliverables across studies.
Coordinate cross-departmental writing activities.
Prepare regulatory and scientific documents such as CSRs, protocols, narratives, PSURs, DSURs, IBs, and eCTD components.
Conduct systematic literature reviews and ensure data integrity.
Peer review documents for quality, clarity, and consistency.
Mentor junior writers and contribute to best practice development within the team.
Maintain awareness of current regulatory standards, authorship ethics, and formatting requirements.
Additional Information
Tasks and responsibilities may be modified as needed.
Equivalent skills or experience will be considered.
Syneos Health is an Equal Opportunity Employer, committed to inclusion, diversity, and compliance with ADA guidelines.
Learn More
🌐 www.syneoshealth.com
Join our Talent Network to stay informed about future opportunities.
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