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

0-2 years

$95,000 – $175,700

Remote

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-AR (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 and manage 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 clarity and scientific accuracy.
Manage 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.

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

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