Job Title: Medical Writer II (CSR Narratives)
Updated: October 15, 2025
Location: IND – Remote
Job ID: 25102321
Company: Syneos Health®
About Syneos Health
Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization focused on accelerating customer success. We combine clinical, medical affairs, and commercial expertise to bring therapies to patients efficiently and effectively.
Our Clinical Development model centers on the customer and patient experience, continuously improving collaboration and operational excellence. With over 29,000 employees across 110 countries, we’re driven by innovation and a shared purpose — Work Here Matters Everywhere.
Why Join Us
Career Growth: Structured career development, technical and therapeutic training.
Supportive Culture: Engaged leadership, peer recognition, and total rewards programs.
Inclusive Environment: Our “Total Self” culture values authenticity, belonging, and diversity of thought.
Global Impact: Worked on 94% of FDA-approved novel drugs and 95% of EMA-authorized products in the last 5 years.
Key Responsibilities
Mentor and guide junior medical writers as needed.
Compile, write, and edit medical writing deliverables with minimal supervision.
Develop and support documents including:
Clinical Study Protocols and Amendments
Clinical Study Reports (CSRs)
Patient Narratives
Annual Reports
Investigator Brochures
Review statistical analysis plans and TFL (Table/Figure/Listing) specs for content, grammar, and consistency.
Collaborate with cross-functional teams (data management, biostatistics, regulatory affairs, etc.).
Serve as an internal peer reviewer ensuring scientific clarity and compliance with templates.
Adhere to regulatory and company standards (ICH-E3, SOPs, client templates).
Conduct literature searches and ensure familiarity with clinical research principles.
Maintain professional development aligned with regulatory and client expectations.
Manage project timelines and budgets, communicating deviations proactively.
Perform other duties as assigned; occasional travel (<25%) may be required.
Qualifications
Education:
Postgraduate (M.Pharm/Master’s) with minimum 1 year of narrative writing experience, or
Graduate (B.Pharm/Bachelor’s) with minimum 2 years of narrative writing experience.
Required Skills:
Strong experience in drafting and reviewing patient narratives.
Excellent command of English grammar, FDA/ICH guidelines, and AMA style.
Proficient in MS Word, Excel, PowerPoint, and online research tools.
Strong presentation, proofreading, and interpersonal communication skills.
Familiarity with clinical data interpretation and clinical research processes.
Ability to work independently while maintaining a team-oriented approach.
Additional Information
Equivalent skills and experience may be considered.
Responsibilities are not exhaustive and may be modified as required.
Syneos Health is an equal opportunity employer committed to diversity, inclusion, and ADA compliance.
Learn More
🌐 www.syneoshealth.com
Join our Talent Network to stay updated on new opportunities.
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