Lead Medical Writer for Regulatory Submissions & Mentorship

Syneos Health India Private Limited; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Syneos Health is seeking a Principal Medical Writer (Regulatory Submission Writing) to develop regulatory documents for global submissions in line with ICH guidelines and company standards. You will manage medical writing projects, coordinate with cross-functional teams, and mentor junior writers to ensure timely, high-quality deliverables.

The role emphasizes process improvement, adherence to timelines, and collaboration across functional areas to support regulatory success for drug development

Responsibilities

• Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and in adherence with study/project timelines and corporate objectives.
• Manage medical writing projects, including developing timelines and cross-functional communication to maintain awareness of review cycles and expectations.
• Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents.
• Review other documents associated with the assigned projects (e.g., Protocols and Statistical Analysis Plans).
• Participate in cross-functional process improvement initiatives.
• Participate in defining and writing standard operating procedures and best practices for efficient preparation of quality documents.
• Manage internal and contract medical writing resources to ensure timely completion of assigned projects.
• Mentor more junior medical writing staff.

Job description

Syneos Health is seeking a Principal Medical Writer (Regulatory Submission Writing) to develop regulatory documents for global submissions in line with ICH guidelines and company standards. You will manage medical writing projects, coordinate with cross-functional teams, and mentor junior writers to ensure timely, high-quality deliverables.

The role emphasizes process improvement, adherence to timelines, and collaboration across functional areas to support regulatory success for drug development