[Hiring] Senior Regulatory Submissions 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 SOPs, 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, 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 processes.
• 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.
• Completes required administrative tasks within specified timeframes.
• Performs other work-related duties as assigned.

Qualifications

• 3-5 years of relevant experience in regulatory writing.
• Experience working in the biopharmaceutical, device, or contract research organization industry required.
• Strong understanding of EMA, 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.
• Minimal travel may be required (less than 25%).

Benefits

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

Salary Range

$70,100.00 - $145,000.00

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.