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

0-2 years

Not Disclosed

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-MS (Remote, East Coast preferred)

🆔 Job ID:

25102046

💰 Salary Range:

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

🎯 Job Overview:

Lead the development and review of complex medical writing deliverables with a focus 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 across the department.

🌟 Key Responsibilities:

🔹 Medical Writing & Publication Deliverables

Lead and manage complex medical writing projects with minimal supervision.
Develop 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
Define document strategy and coordinate activities across departments.
Ensure compliance with ICH E3 guidelines, company SOPs, client standards, templates, and style guides.
Advise clients and internal teams on data presentation and publication strategies.

🔹 Quality Control & Review

Lead document reviews and resolve technical issues.
Serve as an expert peer reviewer for internal teams to ensure clarity, accuracy, and client satisfaction.
Review statistical analysis plans and table/figure/listing (TFL) specifications for format, consistency, and completeness.

🔹 Collaboration & Client Interaction

Build strong relationships with clients, department heads, and cross-functional teams (data management, biostatistics, regulatory affairs, medical affairs).
Represent the medical writing department in meetings, conferences, and client interactions.
Conduct online literature searches and comply with copyright requirements.
Identify issues, propose solutions, and escalate as needed.

🔹 Leadership & Mentoring

Mentor and guide less experienced medical writers on complex documents.
Contribute as a technical SME to internal process improvements and best practices.
Monitor budgets, timelines, and deliverables, communicating changes to leadership.

🔹 Administrative & Miscellaneous

Complete administrative tasks within deadlines.
Perform other 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 organizational and project management abilities.
Ability to work with internal and external stakeholders collaboratively.

🌐 Why Syneos Health:

Inclusive Total Self culture promoting growth, diversity, and belonging.
Work with 29,000 employees in 110 countries.
Participate in 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 a 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.

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

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