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Principal Medical Writer

3-5 years
Not Disclosed
10 Oct. 2, 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:

Principal Medical Writer

πŸ“ Location: USA-OR-Remote (Home-Based)
πŸ†” Job ID: 25100455
πŸ“… Updated: September 25, 2025


Company Overview

Syneos Health® is a global, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success.
We combine clinical, medical affairs, and commercial insights to deliver impactful outcomes addressing modern healthcare challenges.

Our Clinical Development model keeps both the customer and the patient at the center of everything we do. We continuously innovate to simplify workflows and create a culture that’s both rewarding and empowering.

πŸ’‘ “Work Here Matters Everywhere.”
Join 29,000 passionate employees across 110 countries — driving innovation, teamwork, and excellence in every project.


Why Join Syneos Health

  • 🌱 Career Growth: Continuous development, technical & therapeutic training, and clear progression paths.

  • πŸ’¬ Supportive Leadership: Engaged line managers and collaborative teams.

  • 🌍 Total Self Culture: A global culture of authenticity where you can be yourself.

  • 🀝 Diversity & Inclusion: We celebrate diversity of thoughts, backgrounds, and perspectives.

  • πŸ† Rewards & Recognition: Comprehensive rewards, peer recognition, and total well-being programs.


Key Responsibilities

🧾 Document Development & Writing

  • Lead the clear and accurate completion of diverse medical writing deliverables.

  • Prepare regulatory, clinical, and scientific documents including:

    • Clinical study protocols & amendments

    • Clinical study reports & patient narratives

    • Investigator brochures & informed consent forms

    • Annual reports, IND submissions, NDA/eCTD modules

    • Integrated summaries, clinical development plans

    • Periodic safety update reports (PSURs), DSURs

    • Journal manuscripts, abstracts, posters & presentations

πŸ“‹ Compliance & Quality

  • Ensure all deliverables adhere to:

    • ICH E3, FDA/EMA guidelines

    • Company SOPs and client templates

    • Authorship, style, and formatting requirements (AMA Manual of Style)

  • Coordinate editorial and quality reviews, ensuring document consistency and accuracy.

🀝 Cross-functional Collaboration

  • Work closely with teams in Data Management, Biostatistics, Regulatory Affairs, and Medical Affairs.

  • Review statistical analysis plans, tables, figures, and listings for scientific accuracy and consistency.

  • Interact with clients and department heads to ensure expectations are met on time and within budget.

🧠 Research, Mentorship & Leadership

  • Conduct literature searches and ensure compliance with copyright laws.

  • Provide technical guidance, training, and mentorship to junior writers.

  • Identify and implement process improvements in document development.

  • Develop deep expertise in regulatory requirements and therapeutic areas.


Qualifications

  • πŸŽ“ Education:

    • Bachelor’s degree in a relevant discipline required.

    • Graduate degree (Master’s or Ph.D.) preferred.

  • πŸ’Ό Experience:

    • 3–5 years of relevant medical/scientific/technical writing experience.

    • Prior work in biopharmaceutical, medical device, or CRO industry required.

  • πŸ“˜ Knowledge:

    • Strong understanding of FDA, ICH, and Good Publication Practices (GPP3).

    • Familiarity with clinical research principles, data interpretation, and scientific writing standards.

    • Deep knowledge of English grammar and AMA Manual of Style.


Core Skills

  • ✍️ Exceptional scientific writing and proofreading skills.

  • ⏱️ Strong project and time management skills.

  • 🀝 Excellent collaboration and interpersonal abilities.

  • πŸ’» Proficiency in Microsoft Office Suite.

  • 🧠 Strong presentation, analytical, and organizational skills.


About Syneos Health (At a Glance)

  • Partnered with 94% of all Novel FDA Approved Drugs (past 5 years).

  • Supported 95% of EMA Authorized Products.

  • Conducted 200+ studies across 73,000 sites and 675,000+ trial patients.

“No matter your role, you’ll challenge the status quo in a dynamic, ever-evolving environment.”
🌐 Learn more: www.syneoshealth.com


Additional Information

  • Job duties may evolve; equivalent education/experience will be considered.

  • Fully compliant with ADA and EU Equality Directive.

  • Reasonable accommodations available for eligible applicants.


Role Summary (P22 Level)

Role Family: Medical Writing

Primary Focus:

  • Writing and editing regulatory, clinical, and scientific documents.

  • Summarizing raw data and performing literature searches.

  • Supporting regulatory submissions and agency interactions.

Impact:
P22-level roles ensure scientific accuracy, clarity, and compliance in all writing deliverables. They lead complex projects, coordinate cross-functional activities, and ensure adherence to regulatory and quality standards.

Core Focus Areas:

  • βœ… Lead accurate completion of medical writing deliverables

  • βœ… Manage writing activities across studies and departments

  • βœ… Ensure adherence to regulatory and client standards

  • βœ… Conduct quality and peer reviews

  • βœ… Mentor junior writers

  • βœ… Conduct literature searches and develop topic expertise

  • βœ… Manage writing projects within defined budgets


How to Apply

πŸ”— Apply Now
πŸ’‘ Or Join Our Talent Network to stay updated on future opportunities.


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Diversity Statement

Syneos Health is committed to building a diverse, inclusive, and authentic workplace.
If your experience doesn’t perfectly align, apply anyway — we value transferable skills and potential.