๐ง Job Title: Principal Medical Writer
๐
Updated: September 25, 2025
๐ Location: USA-WY-Remote
๐ Job ID: 25100455
๐ข Company: Syneos Health®
๐ 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.
๐ฌ Work Here Matters Everywhere.
๐ Why Work at Syneos Health
๐ Career Growth: Development, training, and progression opportunities
๐ฌ Supportive Management: Engaged line leadership and mentorship
๐ Learning: Technical and therapeutic area training
๐ Recognition: Peer recognition and rewards programs
๐ Inclusive Culture: “Total Self” culture promoting authenticity and belonging
๐ Diversity: Diverse perspectives foster innovation
๐งพ Key Responsibilities
๐๏ธ 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
๐ 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
๐ 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
๐ 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
๐ฅ Mentorship & Expertise
Mentor junior medical writers on complex projects
Develop deep expertise in key therapeutic areas and regulatory requirements
๐ฐ Project & Budget Management
Deliver projects within budget and timelines
๐ 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
๐งฐ 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
๐งญ 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
๐ 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
๐ www.syneoshealth.com
๐ 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
๐ Application
Apply Now or
๐ก Join the Talent Network to stay updated on future opportunities
๐น Past experience doesn’t need to match perfectly; transferable skills are considered.
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