๐ง Job Title: Principal Medical Writer
๐
Updated: September 25, 2025
๐ Location: USA-MN-Remote
๐ Job ID: 25100455
๐ข Company: Syneos Health®
๐ 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.
๐ฌ Work Here Matters Everywhere.
๐ Why Work at Syneos Health
๐ Career Development: Opportunities for growth, training, and progression
๐ฌ Supportive Management: Engaged and collaborative line leadership
๐ Learning Opportunities: Technical and therapeutic area training
๐ Recognition: Peer recognition and total rewards program
๐ Inclusive Culture: “Total Self” culture promoting authenticity and belonging
๐ Diversity: Diverse thoughts and perspectives foster innovation
๐งพ Job Responsibilities
๐๏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
๐ 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
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, consistency, and scientific accuracy
๐ 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
๐ฅ Mentorship & Expertise Development
Mentor junior medical writers
Lead complex projects
Build deep expertise in therapeutic areas and regulatory requirements
๐ฐ Project & Budget Management
Deliver projects on time and within budget
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 knowledge of FDA, ICH, and good publication practices
Expertise in AMA Manual of Style and English grammar
๐งฐ 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
๐งญ 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
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
Positions are at-will employment
๐ Application
Apply Now or
๐ก Join the Talent Network to stay updated on new opportunities
๐น Past experience doesn’t need to match perfectly; transferable skills are considered.
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