Principal Medical Writer

3-5 years

Not Disclosed

Remote, USA

10 Oct. 2, 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

🧠 Job Title: Principal Medical Writer

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

🌍 About Syneos Health

Syneos Health® is a fully integrated biopharmaceutical solutions organization committed to accelerating customer success.
The company translates clinical, medical affairs, and commercial insights into actionable outcomes — putting the customer and patient at the center of its Clinical Development model.

Syneos Health operates with a mission to simplify, innovate, and deliver faster — making the organization easier to work with and work for.

💬 Discover what 29,000 employees across 110 countries already know — Work Here Matters Everywhere.

💎 Why Join Syneos Health

🚀 Career Development & Growth: Structured progression and mentorship
💬 Engaged Leadership: Supportive and collaborative management
🎓 Training: Technical, regulatory, and therapeutic area learning
🏆 Recognition & Rewards: Peer programs and total rewards benefits
🌈 Total Self Culture: Encourages authenticity and belonging
🌍 Diversity & Inclusion: Promotes a workplace where everyone feels valued

🧭 We’re building the company we all want to work for — and our customers want to work with.

🧾 Job Responsibilities

As a Principal Medical Writer, you will lead and deliver high-quality scientific and regulatory documents across clinical programs.

🖋️ Leadership & Oversight

Lead the clear, accurate, and compliant completion of all medical writing deliverables
Manage medical writing activities independently across multiple studies
Coordinate writing efforts within and across departments

📄 Document Creation & Review

Author and finalize diverse document types, including:
- Clinical Study Protocols & Amendments
- Clinical Study Reports (CSRs)
- Investigator Brochures (IBs)
- Patient Narratives
- Informed Consents (ICFs)
- Annual Reports & PSURs
- Clinical Development Plans
- IND & NDA/eCTD Submissions
- Integrated Summary Reports
- Plain Language Summaries
- Journal Manuscripts, Abstracts, Posters, and Presentations

📘 Regulatory & Quality Standards

Adhere to ICH E3, FDA, company SOPs, and client templates
Ensure all documents meet authorship, formatting, and style requirements (AMA Manual of Style)
Coordinate quality and editorial reviews
Conduct peer reviews for consistency, clarity, and format accuracy

📊 Collaboration & Technical Expertise

Review Statistical Analysis Plans (SAPs) and TFL specifications
Collaborate with Data Management, Biostatistics, Regulatory Affairs, and Medical Affairs teams
Conduct literature searches, ensuring copyright compliance
Identify and resolve technical or process issues

👥 Mentorship & Knowledge Building

Mentor and train junior medical writers
Lead complex writing projects
Develop deep regulatory and therapeutic expertise

💰 Budget & Timelines

Manage projects within budget and deadlines

🎓 Qualifications

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

🧰 Key Skills

🔍 Strong proofreading and presentation skills
⏱️ Excellent project and time management
💬 Strong interpersonal and collaborative skills
💻 Proficiency in MS Office Suite
🧬 Understanding of clinical research principles and data interpretation

🧭 Core Focus Areas

✅ Accurate and compliant medical writing deliverables
✅ Cross-functional coordination and communication
✅ Adherence to regulatory and client standards
✅ Quality control and peer review
✅ Mentorship and knowledge sharing
✅ Budget and time management
✅ Literature review and scientific accuracy

📈 Impact & Contribution (P22 Level Overview)

Roles at the P22 level in the Medical Writing job family:

Write and edit clinical, regulatory, and scientific documents
Prepare summaries and reports for regulatory agencies (FDA, EMA)
Conduct literature reviews and summarize data from multiple sources
Prepare briefing books and responses to health authority queries
Review and interpret statistical outputs
Manage entire projects or document suites independently

🎯 These roles ensure clarity, consistency, and scientific accuracy across all regulatory communications.

🌐 About Syneos Health

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

🔗 Website: www.syneoshealth.com

📋 Additional Information

Duties listed are not exhaustive
Equivalent skills or education may substitute listed requirements
Committed to ADA compliance and reasonable accommodations
Adheres to EU Equality Directive and Equal Opportunity Employment
Positions are at-will employment

📝 Application Details

Apply Now or
💡 Join the Talent Network to stay informed on future openings.

🔹 If your experience doesn’t perfectly match, transferable skills are valued. Apply anyway!

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Principal Medical Writer

Job Description

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