Instagram
youtube
Facebook

Sr Principal / Principal Medical Writer (Publication Strategy/Planning) - East Coast Preferred - Single Sponsor

0-2 years
Not Disclosed
10 Oct. 4, 2025
Job Description
Job Type: Full Time 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

🧑‍💼 Position Title:

Sr Principal / Principal Medical Writer (Publication Strategy/Planning)


🌍 Location:

USA-VT (Remote, East Coast Preferred)


🆔 Job ID:

25102046


💰 Salary Range:

$95,000 – $175,700 (base salary; actual varies based on candidate qualifications, skills, and experience)


🎯 Job Overview:

Lead and manage complex medical writing deliverables focused on publication strategy and planning. Collaborate with internal teams and clients to ensure scientific accuracy, regulatory compliance, and timely delivery. Mentor junior writers and contribute to process improvements within the department.


🌟 Key Responsibilities:

🔹 Medical Writing & Publication Deliverables

  • Lead the completion of complex medical writing deliverables with clear and accurate scientific content.

  • Manage medical writing activities for individual studies; define document strategy and coordinate across departments.

  • Complete documents including:

    • Clinical study protocols and amendments

    • Clinical study reports (CSRs)

    • Patient narratives, investigator brochures, informed consents

    • Annual reports, plain language summaries, periodic safety update reports

    • Clinical development plans, IND/NDA/eCTD submissions

    • Journal manuscripts, abstracts, posters, and conference presentations

  • Ensure adherence to ICH E3 guidelines, SOPs, client standards, and approved templates.

  • Advise clients and study teams on data presentation and publication strategies.

🔹 Quality Control & Review

  • Lead team document reviews; resolve technical issues.

  • Serve as peer reviewer to ensure clarity, accuracy, and alignment with client objectives.

  • Review statistical analysis plans and table/figure/listing (TFL) specifications for content, grammar, format, and consistency.

🔹 Collaboration & Client Interaction

  • Build strong working relationships with clients, department heads, and cross-functional teams (data management, biostatistics, regulatory affairs, medical affairs).

  • Represent medical writing department at meetings, conferences, and client presentations.

  • Perform literature searches and ensure copyright compliance.

  • Identify and resolve issues; escalate when necessary.

🔹 Leadership & Mentoring

  • Mentor and guide junior medical writers on complex documents.

  • Serve as technical SME; contribute to process improvements and internal best practices.

  • Monitor budgets, timelines, and deliverables, communicating changes to leadership.

🔹 Administrative & Miscellaneous

  • Complete administrative tasks within specified timeframes.

  • Perform other work-related duties as assigned.

  • Minimal travel required (<25%).


🎓 Qualifications & Requirements:

  • Extensive experience in medical writing, publication planning, and scientific documentation.

  • Deep knowledge of regulatory guidelines (ICH, FDA/EMA, eCTD).

  • Strong leadership, mentoring, and communication skills.

  • Excellent project management and organizational abilities.

  • Ability to collaborate effectively across teams and with clients.


🌐 Why Syneos Health:

  • Inclusive Total Self culture promoting growth, diversity, and belonging.

  • Opportunity to work with 29,000 employees in 110 countries.

  • Experience with FDA-approved and EMA-authorized studies.

  • Benefits include:

    • Medical, Dental, and Vision coverage

    • 401(k) with company match

    • Employee Stock Purchase Plan

    • Performance-based bonuses and commissions

    • Flexible PTO and sick time

    • Car or car allowance (if applicable)


📌 Summary:

The Sr Principal / Principal Medical Writer leads publication strategy and planning efforts, delivering high-quality, compliant medical writing outputs. Acts as mentor and subject matter expert, collaborates with cross-functional teams, advises clients, and ensures timely and accurate completion of deliverables while contributing to process improvements within the department.