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Principal Medical Writer

3-5 years
Not Disclosed
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

๐Ÿง  Job Title: Principal Medical Writer

๐Ÿ“… Updated: September 25, 2025
๐Ÿ“ Location: USA-MN-Remote
๐Ÿ†” Job ID: 25100455
๐Ÿข Company: Syneos Health®


๐ŸŒ 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.

๐Ÿ’ฌ Work Here Matters Everywhere.


๐Ÿ’Ž Why Work at Syneos Health

  • ๐Ÿš€ Career Development: Opportunities for growth, training, and progression

  • ๐Ÿ’ฌ Supportive Management: Engaged and collaborative line leadership

  • ๐ŸŽ“ Learning Opportunities: Technical and therapeutic area training

  • ๐Ÿ† Recognition: Peer recognition and total rewards program

  • ๐ŸŒˆ Inclusive Culture: “Total Self” culture promoting authenticity and belonging

  • ๐ŸŒ Diversity: Diverse thoughts and perspectives foster innovation


๐Ÿงพ Job Responsibilities

๐Ÿ–‹๏ธ 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

๐Ÿ“„ 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

๐Ÿ“˜ 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

๐Ÿ“Š 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

๐Ÿ‘ฅ Mentorship & Expertise Development

  • Mentor junior medical writers

  • Lead complex projects

  • Build deep expertise in therapeutic areas and regulatory requirements

๐Ÿ’ฐ Project & Budget Management

  • Deliver projects on time and within budget


๐ŸŽ“ 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


๐Ÿงฐ 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


๐Ÿงญ 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


๐ŸŒ 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

๐Ÿ”— www.syneoshealth.com


๐Ÿ“‹ 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


๐Ÿ“ Application

  • Apply Now or

  • ๐Ÿ’ก Join the Talent Network to stay updated on new opportunities

๐Ÿ”น Past experience doesn’t need to match perfectly; transferable skills are considered.

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