Job Title
Senior Medical Writer (CSR, IB, Protocol Drafting)
Updated: September 4, 2025
Location: IND-Remote
Job ID: 25100336
About Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization, helping accelerate customer success through clinical, medical affairs, and commercial insights.
29,000 employees across 110 countries.
Supported 94% of FDA Novel Drug Approvals (last 5 years).
Supported 95% of EMA Authorized Products.
Conducted 200+ Studies across 73,000 Sites and 675,000+ Patients.
Our Culture:
Total Self culture – where you can authentically be yourself.
Focus on career growth, training, mentorship, and recognition.
Commitment to diversity, equity, and inclusion.
Creating a workplace where everyone feels like they belong.
Key Responsibilities
Medical Writing & Delivery
Lead and deliver high-quality clinical and regulatory documents.
Ensure accuracy, clarity, and compliance with scientific and regulatory standards.
Document Preparation
Clinical study protocols, amendments, reports, patient narratives.
Annual reports, Investigator Brochures (IB), informed consents.
Plain language summaries, PSURs, clinical development plans.
IND submissions, integrated summaries, NDA & eCTD submissions.
Manuscripts, abstracts, posters, and presentations for scientific meetings.
Compliance & Standards
Adhere to ICH E3, FDA, and other regulatory guidelines.
Follow company SOPs, client standards, templates, and style guides.
Collaboration & Reviews
Coordinate editorial and quality reviews.
Act as peer reviewer to ensure clarity, format, and scientific rigor.
Collaborate with data management, biostatistics, regulatory affairs, and medical affairs teams.
Technical & Analytical Support
Review statistical analysis plans, tables, and figures for accuracy and consistency.
Conduct clinical literature searches, ensuring copyright compliance.
Provide solutions for writing/technical issues and support cross-functional teams.
Mentorship & Leadership
Mentor and guide junior medical writers on complex projects.
Develop expertise in key therapeutic and regulatory areas.
Manage deliverables within budget and timelines.
Qualifications
Education
Bachelor’s degree in a relevant discipline required.
Graduate degree preferred.
Experience
3–5 years in medical, scientific, or technical writing.
Industry experience in biopharma, device, or CRO.
Proven experience with FDA/ICH documents and regulatory submissions.
Knowledge & Skills
Strong knowledge of medical terminology and clinical research principles.
Familiarity with AMA Manual of Style.
Excellent grammar, writing, and editing skills.
Proficiency in MS Office Suite.
Strong time management, project management, and collaboration skills.
Core Focus Areas (P22 Level)
Writing and editing scientific manuscripts, reports, and regulatory documents.
Preparing summaries from raw data for regulatory agencies and internal use.
Conducting literature reviews and revising medical communications.
Reviewing and analyzing statistical outputs for documents such as CSRs and DSURs.
Preparing briefing books and responses to health authority queries.
Leading document coordination, review, and client comment resolution.
Mentoring junior writers and building regulatory expertise.
Additional Information
Tasks listed are not exhaustive; other duties may be assigned.
Equivalent experience/skills/education will be considered.
No employment contract is implied by this description.
Equal Opportunity Employer – compliant with EU Equality Directive & ADA.
How to Apply
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