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-WY-Remote
🆔 Job ID: 25100455
🏢 Company: Syneos Health®

🌍 About Syneos Health

Syneos Health® is a fully integrated biopharmaceutical solutions organization focused on accelerating customer success. The company translates clinical, medical affairs, and commercial insights into actionable outcomes.

Patient & Customer Centric: Clinical development puts patients and customers at the center.
Innovation Driven: Simplifies and streamlines processes for faster, efficient therapy delivery.
Global Presence: 29,000 employees across 110 countries.

💬 Work Here Matters Everywhere.

💎 Why Work at Syneos Health

🚀 Career Growth: Development, training, and progression opportunities
💬 Supportive Management: Engaged line leadership and mentorship
🎓 Learning: Technical and therapeutic area training
🏆 Recognition: Peer recognition and rewards programs
🌈 Inclusive Culture: “Total Self” culture promoting authenticity and belonging
🌍 Diversity: Diverse perspectives foster innovation

🧾 Key Responsibilities

🖋️ Medical Writing & Leadership

Lead the completion of medical writing deliverables clearly and accurately
Manage study-specific medical writing activities independently
Coordinate tasks 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, and Scientific Presentations

📘 Regulatory Compliance & Quality

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

📊 Collaboration & Analysis

Review Statistical Analysis Plans (SAPs) and TFL specifications
Work with Data Management, Biostatistics, Regulatory Affairs, and Medical Affairs
Conduct literature searches while complying with copyright
Identify issues and propose solutions; provide technical support and training

👥 Mentorship & Expertise

Mentor junior medical writers on complex projects
Develop deep expertise in key therapeutic areas and regulatory requirements

💰 Project & Budget Management

Deliver projects within budget and timelines

🎓 Qualifications

Bachelor’s degree in a 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
Proficiency in AMA Manual of Style and English grammar

🧰 Required Skills

Strong proofreading, presentation, collaboration, and interpersonal skills
Excellent project and time management
Proficient in MS Office
Knowledge of medical terminology, clinical research principles, and data interpretation

🧭 Core Focus

Lead clear and accurate medical writing deliverables
Manage study-related writing activities
Ensure regulatory and quality compliance
Peer review and mentor team members
Conduct literature searches and data analysis
Deliver projects on time and within budget

🌐 Company Achievements

Partnered on 94% of Novel FDA-Approved Drugs in the past 5 years
Supported 95% of EMA Authorized Products
Conducted 200+ studies across 73,000 sites involving 675,000+ patients

🔗 www.syneoshealth.com

📋 Additional Information

Job duties are not exhaustive; company may assign additional responsibilities
Equivalent skills or experience may be considered
ADA-compliant; reasonable accommodations available
Complies with EU Equality Directive and equal employment laws
At-will employment; nothing here constitutes a contract

📝 Application

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

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

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Principal Medical Writer

Job Description

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