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-OR (Remote, East Coast preferred)

🆔 Job ID:

25102046

💰 Salary Range:

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

🎯 Job Overview:

Lead the development and review of complex medical writing deliverables, focusing on publication strategy and planning. Provide guidance on data presentation, mentor junior writers, and collaborate with internal and external stakeholders to ensure high-quality, compliant documentation aligned with regulatory and client requirements.

🌟 Key Responsibilities:

🔹 Medical Writing & Publications

Lead completion of complex medical writing deliverables, ensuring clarity, accuracy, and scientific integrity.
Develop a wide variety of 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 submissions, integrated summary reports, NDA/eCTD submissions
- Journal manuscripts, abstracts, posters, and conference presentations
Define document strategy and coordinate medical writing activities within and across departments.
Ensure compliance with ICH E3 guidelines, company SOPs, client standards, templates, and style guides.
Advise clients and study teams on data presentation and production strategies.

🔹 Quality & Review

Lead team document reviews and review documents for technical issues.
Coordinate quality and editorial reviews, managing source documentation appropriately.
Serve as expert peer reviewer for internal team members.
Review statistical analysis plans and table/figure/listing (TFL) specifications for content, format, and consistency.

🔹 Collaboration & Client Interaction

Build and maintain strong relationships with clients, department heads, and cross-functional teams (data management, biostatistics, regulatory affairs, medical affairs).
Participate in internal/external meetings, conferences, and presentations.
Perform clinical literature searches and ensure compliance with copyright requirements.
Identify issues, propose solutions, and escalate as needed.

🔹 Leadership & Mentoring

Mentor and lead less experienced medical writers on complex documents.
Act as a technical SME and contribute to development of internal processes and materials.
Advise on budget specifications, timelines, and deliverables.

🔹 Administrative & Miscellaneous

Complete required administrative tasks within specified timeframes.
Perform other work-related duties as assigned.
Minimal travel may be required (<25%).

🎓 Qualifications & Requirements:

Extensive experience in medical writing, publication strategy, and planning.
In-depth knowledge of regulatory guidelines and standards (ICH, FDA/EMA, eCTD).
Strong leadership, mentoring, and interpersonal skills.
Excellent organizational skills, attention to detail, and ability to manage multiple deliverables.
Ability to collaborate effectively with internal and external stakeholders.

🌐 Why Syneos Health:

Inclusive Total Self culture fostering belonging, professional growth, and diversity.
Work with 29,000 employees in 110 countries.
Participate in FDA-approved and EMA-authorized studies.
Benefits include Medical, Dental, Vision, 401k match, Employee Stock Purchase Plan, performance-based bonuses, flexible PTO, and sick time.

📌 Summary:

This role leads publication strategy and planning, delivering high-quality medical writing outputs across the clinical development lifecycle. Acts as mentor, technical expert, and client liaison, ensuring clarity, regulatory compliance, and timely completion of all deliverables. Contributes to internal process improvements and supports strategic publication objectives.

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

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