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

0-2 years
$95,000 – $175,700
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-ME (Remote, East Coast Preferred)


🆔 Job ID:

25102046


💰 Salary Range:

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


🎯 Job Overview:

Lead the development and management of complex medical writing deliverables with a focus on publication strategy and planning. Collaborate with cross-functional teams and clients to ensure scientific accuracy, regulatory compliance, and timely delivery. Mentor junior writers and drive continuous improvement in medical writing processes.


🌟 Key Responsibilities:

🔹 Medical Writing & Publication Deliverables

  • Lead completion of complex medical writing deliverables, ensuring scientific clarity and accuracy.

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

  • Prepare 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 compliance with ICH E3 guidelines, SOPs, client standards, and approved templates.

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

🔹 Quality Control & Review

  • Lead document reviews and resolve technical issues.

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

  • Review statistical analysis plans and table/figure/listing (TFL) specifications for consistency and formatting.

🔹 Collaboration & Client Interaction

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

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

  • Conduct literature searches and ensure copyright compliance.

  • Identify and resolve issues; escalate as appropriate.

🔹 Leadership & Mentoring

  • Mentor junior medical writers on complex documents.

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

  • Track budgets, timelines, and deliverables; communicate updates to leadership.

🔹 Administrative & Miscellaneous

  • Complete administrative tasks within deadlines.

  • Perform other work-related duties as assigned.

  • Minimal travel (<25%).


🎓 Qualifications & Requirements:

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

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

  • Strong leadership, mentoring, and communication skills.

  • Excellent project management and organizational abilities.

  • Ability to collaborate effectively with clients and internal teams.


🌐 Why Syneos Health:

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

  • 29,000 employees across 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, delivering high-quality, compliant medical writing outputs. Acts as mentor and SME, collaborates with cross-functional teams, advises clients, and ensures timely and accurate completion of deliverables while contributing to process improvements.