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-AK (Remote, East Coast preferred)

🆔 Job ID:

25102046

💰 Salary Range:

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

🎯 Job Overview:

Responsible for leading medical writing deliverables with a focus on publication strategy and planning. Provides guidance on data presentation, ensures high-quality documentation, and mentors less experienced writers. Works closely with clients, internal teams, and cross-functional stakeholders to deliver accurate, clear, and compliant scientific content.

🌟 Key Responsibilities:

🔹 Medical Writing & Publications

Lead and complete complex medical writing deliverables, including:
- Clinical study protocols and amendments
- Clinical study reports (CSRs)
- Patient narratives, annual reports, investigator brochures
- Informed consents, 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 documents comply with ICH E3 guidelines, company SOPs, client standards, templates, and style guides.
Advise clients and study teams on data presentation strategies to meet objectives.

🔹 Quality & Review

Review documents for technical issues, grammar, formatting, and consistency.
Coordinate quality and editorial reviews and manage source documentation appropriately.
Serve as an internal peer reviewer, providing feedback to ensure clarity, accuracy, and adherence to client expectations.
Review statistical analysis plans and TFL (Tables, Figures, Listings) specifications to ensure alignment with document requirements.

🔹 Collaboration & Client Interaction

Build 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 and propose solutions to issues; 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 materials, presentations, and processes.
Provide guidance on timelines, deliverables, and budget adherence.

🔹 Administrative & Miscellaneous

Complete administrative tasks within specified timeframes.
Minimal travel may be required (<25%).

🎓 Qualifications & Requirements:

Advanced experience in medical writing, publication planning, and strategy.
Expertise in regulatory guidelines and standards (ICH, eCTD, FDA/EMA regulations).
Strong leadership, mentoring, and communication skills.
Ability to collaborate with internal and external stakeholders.
Strong organizational skills, attention to detail, and ability to manage multiple deliverables simultaneously.

🌐 Why Syneos Health:

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

📌 Summary:

The Sr Principal / Principal Medical Writer leads publication strategy and planning initiatives, delivering high-quality clinical documents across the development lifecycle. Acts as a mentor, technical SME, and key liaison with clients and internal teams to ensure clarity, accuracy, compliance, and timely completion of deliverables. Supports strategic decisions regarding publications while ensuring adherence to regulatory standards and company guidelines.

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