Associate Director, Regulatory Strategic Writing

The Associate Director of Regulatory Strategic Writing (RSW) is responsible for providing leadership and direction for clinical and regulatory writing projects for one large or multiple compounds within a therapeutic area within budget, with quality, and in accordance with timelines.

Responsibilities:

• Directly leads multiple individual contributors located in geographically disbursed locations with oversight of both internal and external staff. Assists in the selection of freelance consultants or other vendors.
• Participates in continual improvement across Strategic Medical Writing best practices, processes, and performance. Leads execution of cross-functional initiatives.
• Effectively utilizes project management tools/techniques to drive multiple projects; responsible for overall project management for several projects simultaneously.
• Works with cross-functional project teams to develop project objectives, strategies, corresponding timelines, and milestones. Coordinates activities and communications on writing projects/submissions utilizing cross-functional skills/expertise and drug development knowledge. Holds team members to the project tasks/deliverables.
• Participates in continual improvement across Strategic Medical Writing best practices, processes, and performance. Leads execution of cross-functional initiatives.
• Collects appropriate metrics for assigned therapeutic area.
• Maintains expert knowledge of US and international regulations, requirements and guidance associated with preparation of regulatory documentation and serves as a company-wide subject matter expert and liaison for other functions to ensure the application of highest industry standards. Learns and applies therapeutic area and product knowledge to scientific projects and business improvement projects.
• Maintains inspection readiness for assigned remit. May act as the organizational representative in regulatory inspections and quality audits.
• Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required