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Medical Writer Ii (Csr Narratives)

2+ years
Not Disclosed
10 Oct. 19, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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
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