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 by bringing together clinical, medical affairs, and commercial expertise.
With over 29,000 employees across 110 countries, our mission is to place the customer and patient at the center of everything we do. We aim to simplify, innovate, and accelerate the delivery of life-changing therapies.
Motto: Work Here Matters Everywhere.
Why Join Syneos Health
Career growth and continuous professional development.
Supportive and engaged management with a focus on mentorship.
Technical and therapeutic area training.
Peer recognition and total rewards program.
“Total Self” Culture — authenticity, inclusivity, and belonging.
A diverse, global workplace where every perspective matters.
Job Summary
The Medical Writer II (CSR Narratives) will be responsible for drafting, editing, and reviewing clinical and regulatory documents with minimal supervision. The role involves mentoring junior writers, ensuring adherence to ICH and company guidelines, and maintaining high scientific and editorial standards.
Key Responsibilities
Writing and Documentation
Prepare, write, and edit medical writing deliverables including:
Clinical Study Protocols and Amendments
Clinical Study Reports (CSRs)
Patient Narratives
Annual Reports
Investigator Brochures
Conduct literature searches to support content development.
Review statistical analysis plans and TFL (Tables, Figures, Listings) for accuracy and consistency.
Collaboration and Review
Collaborate with Data Management, Biostatistics, Regulatory Affairs, and Medical Affairs teams.
Serve as peer reviewer for internal documents to ensure clarity, consistency, and scientific integrity.
Mentor less experienced writers when needed.
Compliance and Quality
Ensure adherence to:
ICH-E3 and FDA guidelines
Company SOPs and templates
Client-specific requirements
Maintain awareness of budget, timelines, and project deliverables.
Continue professional development to stay current with evolving regulatory and industry standards.
Administrative
Complete all assigned administrative and compliance tasks on time.
Travel may be required (< 25%).
Qualifications
Education
Master’s degree (M.Pharm / Life Sciences) with minimum 1 year experience in narratives
OR
Bachelor’s degree with minimum 2 years experience in narratives.
Skills and Competencies
Strong command of English grammar and familiarity with AMA style guide.
Thorough understanding of ICH and FDA regulations.
Proven ability to interpret and present clinical and statistical data.
High attention to detail with strong proofreading and editing skills.
Proficient in MS Word, Excel, PowerPoint, Email, and Internet tools.
Excellent communication, leadership, and teamwork skills.
About Syneos Health’s Global Impact
Partnered in 94% of all FDA-approved novel drugs and 95% of EMA-authorized products in the past 5 years.
Conducted 200+ studies across 73,000 sites involving 675,000+ trial participants.
Website: www.syneoshealth.com
Additional Information
Responsibilities listed are not exhaustive; additional duties may be assigned as required.
Equivalent education, experience, or skills may be considered.
Syneos Health is committed to diversity, inclusion, and providing reasonable accommodations under the Americans with Disabilities Act (ADA).
The company fully complies with EU Equality Directives and global employment legislation.
How to Apply
Apply Now: Syneos Health Careers
Not ready to apply? Join our Talent Network to stay informed about upcoming opportunities.
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