[Hiring] Senior / Principal Medical Writer @Syneos Health

Role Description

The Sr. / Principal Medical Writer (Regulatory focus) is responsible for leading the completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately. Key responsibilities include:

• Leads the clear and accurate completion of medical writing deliverables.
• Manages medical writing activities associated with individual studies.
• Completes a variety of documents, including:
  • Clinical study protocols and 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
  • Abstracts, posters, and presentations for scientific meetings
• Adheres to established regulatory standards and company procedures.
• Coordinates quality and editorial reviews.
• Acts as peer reviewer for internal team documents.
• Reviews statistical analysis plans and provides feedback.
• Interacts and builds good working relations with clients and peers.
• Performs online clinical literature searches.
• Identifies and proposes solutions to resolve issues.
• Mentors and leads less experienced medical writers.
• Develops deep expertise on key topics in the industry.
• Aware of budget specifications for assigned projects.
• Completes required administrative tasks within specified timeframes.
• Performs other work-related duties as assigned.
• Minimal travel may be required (less than 25%).

Qualifications

• Minimum of 5 years of lead regulatory writing experience.
• Experience with Phase 2 and 3.
• Lead writer experience with:
  • Protocols
  • Submissions
  • Clinical Summary of Safety (CTD) Modules 2.7.3 and 2.7.4
  • CSRs (Clinical Study Reports)
  • IBs (Investigator Brochure)
  • Patient Narratives
  • Safety Aggregate Reports
  • Briefing books
  • ISE and ISS (Integrated Summary Efficacy and Integrated Summary Safety)
• Strong project management skills.
• Strong client experience.
• Time management skills a must.
• Process experience is a huge plus.
• Remote – Open to US and Canada.

Requirements

• Strong project management skills.
• Strong client experience.
• Time management skills a must.
• Process experience is a huge plus.

Benefits

• Company car or car allowance.
• Health benefits including Medical, Dental, and Vision.
• Company match 401k.
• Eligibility to participate in Employee Stock Purchase Plan.
• Eligibility to earn commissions/bonus based on company and individual performance.
• Flexible paid time off (PTO) and sick time.

Company Description

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change, and accelerate progress.

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.