SL
Senior Medical Writer - Europe / home based - FSP Team
Contract type
Ongoing
Work mode
Remote
Experience
Mid-level · 3+ years
Job description
Senior Medical Writer within Syneos Health's FSP Team, leading the completion of medical writing deliverables for clinical studies and regulatory submissions. The role coordinates medical writing activities across departments and serves as a client-facing lead on document review and resolution.
At a glance
- Employment
- Full-time · Employee (employment agreement)
- Work mode
- Remote
- Languages
- English
What you'll do
- Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately
- Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision
- Leads the resolution of comments from the client
- Completes a variety of documents that may include clinical study protocols and protocol amendments, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, post
- Adheres to established regulatory standards including ICH E3 guidelines, company SOPs, client standards, approved templates, authorship requirements, and style and formatting guides, on time and on budget
- Coordinates quality and editorial reviews; ensures source documentation is managed appropriately; leads team document reviews and reviews documents as needed
- Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format
- Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency; provides feedback to further define statistical output required and document needs
- Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs
- Performs online clinical literature searches and complies with copyright requirements
- Identifies and proposes solutions to resolve issues, escalating as appropriate; provides technical support, training, and consultation to department and other company staff
- May contribute to development of internal materials and presentations or changes to internal process, standard practices, and capabilities
- Mentors and leads less experienced medical writers on complex projects, as necessary
- Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing
- Aware of budget specifications for assigned projects, working within the budgeted hours and communicating status and changes to medical writing leadership
- Completes required administrative tasks within the specified timeframes
- Performs other work-related duties as assigned
- Minimal travel may be required (less than 25%)
What we're looking for
- 3-5 years of relevant experience in science, technical, or medical writing
- Veeva Vault - MUST HAVE
- Tech Savy - comfortable using technology
- Experience working in the biopharmaceutical, device, or contract research organization industry required
- Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required
- Experience writing relevant document types required
- Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style
Nice to have
- FSP or CRO experience preferred
Your team
FSP Team
Functional Service Provider partnership team within Clinical Solutions
Benefits
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Inclusive culture
Apply
About Syneos Health
A leading fully-integrated life sciences services organization built to accelerate customer success
Syneos Health partners with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
Key facts
- 25,000
- Life sciences services
- Over the past 5 years, worked with 94% of all Novel FDA Approved Drugs
- 95% of EMA Authorized Products
- Over 200 Studies across 73,000 Sites and 675,000+ Trial patients
What they value
- Driven to Deliver
- Inclusive culture
- Passionate about developing our people