๐ง Job Title: Principal Medical Writer
๐
Updated: September 25, 2025
๐ Location: USA-IA-Remote
๐ Job ID: 25100455
๐ข Company: Syneos Health®
๐ About Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization that partners with clients to accelerate success. The company combines clinical, medical affairs, and commercial insights to address modern market realities.
With 29,000 employees across 110 countries, Syneos Health’s mission is to bring patients and customers to the center of everything they do — streamlining processes and driving innovation.
๐ก Work Here Matters Everywhere.
๐ Why Work at Syneos Health
๐ Career growth through structured development & progression
๐ฌ Engaged line management & supportive team culture
๐ Technical and therapeutic area training
๐ Peer recognition & total rewards program
๐ Total Self Culture – authenticity, inclusion & belonging
๐ Diverse perspectives = better outcomes for employees and clients
๐งพ Job Responsibilities
As a Principal Medical Writer, you will:
๐๏ธ Medical Writing Leadership
Lead the clear and accurate completion of all medical writing deliverables
Ensure scientific clarity, accuracy, and regulatory compliance
Manage writing activities for individual studies with minimal supervision
๐ Document Development
Prepare and review key regulatory and scientific documents, including:
Clinical Study Protocols & Amendments
Clinical Study Reports (CSRs)
Investigator Brochures (IBs)
Informed Consents (ICFs)
Patient Narratives
Annual Reports
Periodic Safety Update Reports (PSURs)
Clinical Development Plans
IND Submissions
NDA/eCTD Submissions
Plain Language Summaries
Manuscripts, Abstracts, Posters, & Presentations
๐ Compliance & Quality
Adhere to ICH E3, FDA, and company SOPs and templates
Conduct quality & editorial reviews
Perform peer reviews to ensure consistency, clarity, and format accuracy
Conduct clinical literature searches and ensure copyright compliance
๐ฅ Collaboration & Mentorship
Collaborate with cross-functional teams:
Data Management
Biostatistics
Regulatory Affairs
Medical Affairs
Mentor and guide junior medical writers
Provide technical support, training, and consultation
๐ก Additional Duties
Review statistical analysis plans and TFL specifications
Develop deep expertise in regulatory and industry requirements
Work within budget specifications and timelines
๐ Qualifications
๐ Bachelor’s degree in a relevant scientific discipline (Master’s/PhD preferred)
๐ง 3–5 years of relevant experience in medical/scientific/technical writing
๐ผ Experience in biopharma, device, or CRO industry required
๐ Strong knowledge of FDA, ICH, and good publication practices
โ๏ธ Expertise in AMA Manual of Style and English grammar
๐งฐ Required Skills
๐ Exceptional proofreading & presentation skills
๐ค Strong interpersonal & collaboration skills
๐๏ธ Excellent time and project management abilities
๐ป Proficiency in MS Office Suite
๐ฌ Strong understanding of medical terminology & clinical research principles
๐ Key Impact Areas
Lead and deliver high-quality medical writing outputs
Ensure regulatory compliance and scientific integrity
Coordinate across teams to meet project goals
Act as a peer reviewer and mentor for team members
Develop industry-specific expertise and maintain best practices
๐งฉ Core Focus Areas
โ Clear and accurate medical writing deliverables
โ Departmental coordination
โ Adherence to ICH and client standards
โ Quality control and peer review
โ Collaboration with cross-functional teams
โ Mentorship and knowledge sharing
โ Literature review and compliance
โ On-time, within-budget delivery
๐ About the Company
๐ Worked with 94% of Novel FDA Approved Drugs (last 5 years)
๐งฌ Supported 95% of EMA Authorized Products
๐งฉ Completed 200+ Studies across 73,000 Sites and 675,000+ Trial Patients
๐ Website: www.syneoshealth.com
๐ Additional Information
Tasks and duties are not exhaustive and may evolve
Equivalent experience or education may substitute requirements
Compliant with ADA and committed to reasonable accommodations
Committed to diversity, inclusion, and equal opportunity
๐งญ Summary (P22 Level Overview)
P22-level Medical Writers are responsible for:
Writing and editing clinical & regulatory documents
Conducting literature reviews & data analysis
Preparing submission documents and scientific communications
Engaging with regulatory agencies through briefing books & responses
Managing entire projects with autonomy
They ensure scientific clarity, regulatory accuracy, and cross-functional collaboration while mentoring others and driving operational excellence.
๐ Application
Apply Now or
๐ Join the Talent Network to stay updated on opportunities.
๐ฌ Even if your experience doesn’t align perfectly, transferable skills are valued. Apply anyway!
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