Principal Medical Writer

3-5 years

Not Disclosed

Remote, USA

10 Oct. 2, 2025

Job Description

Job Type: Full Time Remote 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

🧠 Job Title: Principal Medical Writer

📅 Updated: September 25, 2025
📍 Location: USA-MA-Remote
🆔 Job ID: 25100455
🏢 Company: Syneos Health®

🌍 About Syneos Health

Syneos Health® is a fully integrated biopharmaceutical solutions organization, accelerating customer success by translating clinical, medical affairs, and commercial insights into outcomes.

Patient & Customer Centric: Clinical Development model places the patient and customer at the center
Innovation Driven: Simplifies and streamlines work to deliver therapies faster
Global Presence: 29,000 employees across 110 countries

💬 Work Here Matters Everywhere.

💎 Why Syneos Health

🚀 Career Growth: Development, training, and progression opportunities
💬 Supportive Management: Engaged line leadership
🎓 Learning & Training: Therapeutic and technical area training
🏆 Recognition: Peer recognition and total rewards
🌈 Inclusive Culture: Total Self culture promotes authenticity and belonging
🌍 Diversity & Collaboration: Diverse perspectives drive innovation

🧾 Job Responsibilities

🖋️ Leadership & Oversight

Lead accurate completion of medical writing deliverables
Manage writing activities for studies independently
Coordinate across departments with minimal supervision

📄 Document Creation

Prepare and review:

Clinical Study Protocols & Amendments
Clinical Study Reports (CSRs)
Investigator Brochures (IBs)
Patient Narratives & Informed Consents (ICFs)
Annual Reports & Periodic Safety Update Reports (PSURs)
Clinical Development Plans, IND & NDA/eCTD Submissions
Integrated Summary Reports
Plain Language Summaries
Journal Manuscripts, Abstracts, Posters, Scientific Presentations

📘 Regulatory & Quality Compliance

Ensure adherence to ICH E3, FDA, SOPs, client templates, and style guides
Coordinate quality and editorial reviews
Conduct peer reviews for clarity, consistency, and format

📊 Collaboration & Analysis

Review Statistical Analysis Plans (SAPs) and table/figure/listing (TFL) specifications
Work with Data Management, Biostatistics, Regulatory Affairs, and Medical Affairs teams
Conduct literature searches and comply with copyright requirements
Identify and resolve technical/process issues

👥 Mentorship & Knowledge Development

Mentor junior medical writers
Lead complex projects
Build expertise in therapeutic areas and regulatory requirements

💰 Budget & Project Management

Deliver projects on time and within budget

🎓 Qualifications

🎓 Bachelor’s degree in relevant scientific discipline (graduate degree preferred)
🧠 3–5 years of experience in medical, scientific, or technical writing
💼 Experience in biopharmaceutical, device, or CRO industry
📘 Strong understanding of FDA, ICH, and good publication practices
✍️ Expertise in AMA Manual of Style and English grammar

🧰 Key Skills

🔍 Strong proofreading, presentation, and collaboration skills
⏱️ Excellent project and time management
💻 Proficiency in MS Office Suite
🧬 Understanding of medical terminology, clinical research principles, and data interpretation

🧭 Core Focus

✅ Accurate, compliant medical writing
✅ Coordination across departments and teams
✅ Regulatory and quality adherence
✅ Peer review and mentorship
✅ Literature search and data analysis
✅ Budget and timeline management

📈 Impact & Contribution (P22 Level)

Write, edit, and review clinical and scientific documents
Summarize data for regulatory submissions and internal use
Conduct systematic literature searches and reviews
Prepare briefing books and regulatory responses
Lead projects or processes independently
Ensure clarity, accuracy, and regulatory compliance in all communications

🌐 About Syneos Health Achievements

Partnered on 94% of Novel FDA-Approved Drugs (last 5 years)
Supported 95% of EMA Authorized Products
Executed 200+ studies across 73,000 sites involving 675,000+ patients

🔗 www.syneoshealth.com

📋 Additional Information

Job duties are not exhaustive
Equivalent skills or experience may be considered
ADA compliant and supports reasonable accommodations
Complies with EU Equality Directive and equal employment laws
Positions are at-will employment

📝 Application

Apply Now or
💡 Join the Talent Network to stay updated on new opportunities

🔹 Past experience doesn’t need to match perfectly; transferable skills are considered.

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Principal Medical Writer

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