[Hiring] Senior/Principal Medical Writer @Syneos Health

Role Description

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 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, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates.
• Coordinates quality and editorial reviews. Ensures source documentation is managed appropriately.
• 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.
• Interacts and builds good working relations with clients, department heads, 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, providing technical support, training, and consultation to department and other company staff.
• Mentors and leads less experienced medical writers on complex projects.
• Develops deep expertise on key topics in the industry and regulatory requirements affecting medical writing.
• Aware of budget specifications for assigned projects, working within budgeted hours and communicating status and changes to medical writing leadership.
• 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.
• Lead writing experience must include:
• Experience with Phase 2 and 3.
• Protocols, submissions, clinical Summary of Safety (CTD) Modules 2.7.3 and 2.7.4, CSRs, IBs, Patient Narratives, Safety Aggregate Reports, Briefing books, ISE, and ISS.
• Strong project management skills.
• Strong client experience.
• Time management skills a must.
• Process experience is a huge plus.
• Remote – Open to US, UK, and Canada.

Benefits

• Passionate about developing our people through career development and progression.
• Supportive and engaged line management.
• Technical and therapeutic area training.
• Peer recognition and total rewards program.
• Commitment to building an inclusive culture.
• Opportunity to shape solutions that impact lives.
• Collaboration with smart colleagues from across the world.

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.