Senior Medical Writer (CSR, IB, Protocol Drafting)
Location: IND-Remote
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
Agile, collaborative, and innovative teams
29,000 employees across 110 countries
Global Impact:
94% of novel FDA-approved drugs and 95% of EMA-authorized products in last 5 years
200+ studies across 73,000 sites and 675,000+ trial patients
Learn more: www.syneoshealth.com
Why Syneos Health
Career Growth: Training, peer recognition, and career progression
Inclusive Culture: Total Self culture fostering authenticity and belonging
Collaboration: Cross-functional teamwork to achieve customer goals
Role Summary
The Senior Medical Writer ensures the clear, accurate, and timely completion of medical writing deliverables. The role involves managing writing activities across studies, mentoring junior writers, reviewing statistical outputs, and collaborating with cross-functional teams while adhering to regulatory guidelines.
Core Responsibilities
Medical Writing & Document Management
Prepare and edit 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: ICH E3 guidelines, SOPs, client standards, approved templates
Coordinate quality and editorial reviews; ensure source documentation is maintained
Review statistical analysis plans, TFL specifications for content, grammar, and format
Collaboration & Client Interaction
Build strong relationships with clients and internal teams in:
Data Management, Biostatistics, Regulatory Affairs, Medical Affairs
Act as peer reviewer for internal documents
Perform literature searches and ensure copyright compliance
Leadership & Mentorship
Mentor and guide junior medical writers
Provide technical support, training, and consultation
Develop expertise in regulatory requirements and industry practices
Project & Budget Management
Manage medical writing activities with minimal supervision
Ensure deliverables are completed within budget and timelines
Identify and propose solutions for workflow or technical challenges
Qualifications & Experience
Bachelor’s degree in relevant discipline; graduate degree preferred
3–5 years of experience in scientific, technical, or medical writing
Experience in biopharmaceutical, device, or CRO industries
Strong knowledge of FDA, ICH, and Good Publication Practices (GPP)
Experience preparing CSRs, IBs, protocols, manuscripts, PSURs, and regulatory submissions
Key Skills
Excellent written and verbal communication; mastery of AMA Manual of Style
Strong project and time management skills
Proficiency in MS Office
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 and responsibilities may be adjusted at company 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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