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

🌍 About Syneos Health

Syneos Health® is a fully integrated biopharmaceutical solutions organization, helping customers accelerate success by translating clinical, medical affairs, and commercial insights into actionable outcomes.

Patient & Customer Centric: Our Clinical Development model puts the patient and customer at the center.
Innovation Driven: Streamlines processes to deliver therapies faster and more efficiently.
Global Presence: 29,000 employees across 110 countries.

💬 Work Here Matters Everywhere.

💎 Why Work at Syneos Health

🚀 Career Development: Opportunities for growth, training, and progression
💬 Supportive Management: Engaged and collaborative line leadership
🎓 Learning Opportunities: Technical and therapeutic area training
🏆 Recognition: Peer recognition and total rewards program
🌈 Inclusive Culture: “Total Self” culture promoting authenticity and belonging
🌍 Diversity: Diverse thoughts and perspectives foster innovation

🧾 Job Responsibilities

🖋️ Medical Writing & Leadership

Lead the completion of medical writing deliverables accurately and clearly
Manage writing activities for studies independently
Coordinate activities across departments with minimal supervision

📄 Document Development

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, consistency, and scientific accuracy

📊 Collaboration & Analysis

Review Statistical Analysis Plans (SAPs) and table/figure/listing (TFL) specifications
Collaborate with Data Management, Biostatistics, Regulatory Affairs, and Medical Affairs teams
Perform literature searches while complying with copyright
Identify issues and propose solutions; provide technical support and training

👥 Mentorship & Expertise Development

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

💰 Project & Budget Management

Deliver projects on time and within budget

🎓 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 knowledge of FDA, ICH, and good publication practices
Expertise in AMA Manual of Style and English grammar

🧰 Required Skills

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

🧭 Core Focus

Leading clear and accurate medical writing deliverables
Coordinating across departments and teams
Ensuring regulatory and quality compliance
Reviewing and mentoring internal team
Performing literature searches and data analysis
Managing projects within budget and timelines

🌐 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
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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