Senior Medical Writer (CSR, IB, Protocol Drafting)
Location: IND-Gurugram (Hybrid)
Updated: September 4, 2025
Job ID: 25100336
Company Overview
Syneos Health® is a fully integrated biopharmaceutical solutions organization focused on accelerating customer success by translating clinical, medical, and commercial insights into outcomes.
Patient- and customer-centric Clinical Development model
Simplifying and streamlining processes for efficient collaboration
Agile, collaborative, and innovative teams
Global Impact:
29,000 employees across 110 countries
Supported 94% of novel FDA-approved drugs and 95% of EMA-authorized products in the last 5 years
200+ studies across 73,000 sites and 675,000+ trial patients
Learn more: www.syneoshealth.com
Why Syneos Health
Career Growth: Technical and therapeutic training, peer recognition, career progression
Inclusive Culture: Total Self culture fostering authenticity, diversity, and belonging
Collaborative Environment: Cross-functional teamwork to achieve customer goals
Role Summary
The Senior Medical Writer is responsible for producing and reviewing high-quality medical writing deliverables, ensuring scientific and regulatory accuracy. The role manages writing activities across studies, mentors junior writers, and collaborates with cross-functional teams.
Core Focus:
Lead medical writing deliverables
Manage writing activities within and across departments
Ensure regulatory compliance and adherence to guidelines
Mentor and guide junior writers
Key Responsibilities
Medical Writing & Document Management
Prepare and edit a variety of documents, including:
Clinical Study Protocols (CSP), Amendments
Clinical Study Reports (CSR), Integrated Summary Reports
Investigator Brochures (IB)
Informed Consents, Plain Language Summaries
Periodic Safety Update Reports (PSURs), Clinical Development Plans
IND, NDA, eCTD submissions
Journal manuscripts, abstracts, posters, scientific presentations
Adhere to regulatory standards, including ICH E3 guidelines, SOPs, client standards, and approved templates
Perform quality and editorial reviews; ensure proper source documentation management
Review statistical analysis plans, TFL specifications for clarity, format, and consistency
Collaboration & Client Interaction
Build strong relationships with clients, department heads, and peers in:
Data Management
Biostatistics
Regulatory Affairs
Medical Affairs
Act as peer reviewer to ensure scientific accuracy and clarity
Conduct literature searches and ensure copyright compliance
Leadership & Mentorship
Mentor and lead junior medical writers on complex projects
Provide technical guidance, training, and consultation
Develop expertise in regulatory requirements and industry best practices
Project & Budget Management
Manage writing activities with minimal supervision
Ensure timely completion of deliverables within budget specifications
Identify and propose solutions for workflow or technical challenges
Qualifications & Experience
Education: Bachelor’s degree in a relevant discipline; graduate degree preferred
Experience: 3–5 years in scientific, technical, or medical writing
Industry: Biopharmaceutical, device, or CRO experience required
Regulatory Knowledge: FDA, ICH guidelines, and Good Publication Practices (GPP)
Document Expertise: CSR, IB, protocols, manuscripts, PSURs, submissions, scientific communications
Key Skills
Strong written and verbal communication; mastery of English grammar (AMA Manual of Style)
Project and time management skills
Proficiency in MS Office (Word, Excel, PowerPoint)
Understanding of medical terminology and clinical research principles
Ability to interpret and present complex clinical data clearly
Collaborative, interpersonal, and presentation skills
Additional Information
Tasks may be adjusted at the company’s discretion
Equivalent skills and experience will be considered
Compliance with employment legislation and ADA requirements
How to Apply
Apply via Syneos Health careers portal
Join the Talent Network for future opportunities
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