[Hiring] Principal Medical Writer @Syneos Health

Role Description

The Principal Medical Writer (Regulatory) will lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately. Responsibilities include:

• Managing medical writing activities associated with individual studies, coordinating activities within and across departments with minimal supervision.
• Leading the resolution of comments from the client.
• Completing 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
• Adhering to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates.
• Coordinating quality and editorial reviews, ensuring source documentation is managed appropriately.
• Acting as a peer reviewer for internal teams to ensure document scientific content, clarity, overall consistency, and proper format.
• Reviewing statistical analysis plans and providing feedback on content, grammar, format, and consistency.
• Interacting and building good working relations with clients, department heads, and peers in various departments.
• Performing online clinical literature searches and complying with copyright requirements.
• Identifying and proposing solutions to resolve issues, providing technical support, training, and consultation.
• Mentoring and leading less experienced medical writers on complex projects.
• Developing deep expertise on key industry topics and regulatory requirements affecting medical writing.
• Aware of budget specifications for assigned projects, working within budgeted hours.
• Completing required administrative tasks within specified timeframes.
• Performing other work-related duties as assigned.
• Minimal travel may be required (less than 25%).

Qualifications

• Experience in medical writing, particularly in regulatory submissions.
• Strong understanding of regulatory standards and guidelines.
• Excellent communication and interpersonal skills.
• Ability to manage multiple projects and deadlines.

Requirements

• Proven ability to produce high-quality documents under tight deadlines.
• Experience with statistical analysis plans and data interpretation.
• Strong attention to detail and organizational skills.

Benefits

• Career development and progression opportunities.
• Supportive and engaged line management.
• Technical and therapeutic area training.
• Peer recognition and total rewards program.
• Inclusive culture where you can authentically be yourself.