Associate Director, Regulatory Strategic Writing - Remote

Overview

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.

In Short

• Directly leads multiple individual contributors located in geographically disbursed locations.
• Participates in continual improvement across Strategic Medical Writing best practices.
• Effectively utilizes project management tools to drive multiple projects.
• Works with cross-functional project teams to develop project objectives and timelines.
• Maintains expert knowledge of US and international regulations.
• May act as the organizational representative in regulatory inspections.
• Requires continuous sitting for prolonged periods.

Requirements

• A minimum of 8 years of bio-pharmaceutical industry experience.
• Minimum of 2-3 years of people management experience.
• Bachelor's Degree or higher required; scientific discipline preferred.
• Demonstrated high level of competency in leadership behaviors.
• Experience implementing large-scale change and process improvements.
• Builds relationships and gains cross-functional alignment.
• Excellent business and financial aptitude.
• Experience leading scaled global teams.

Benefits

• Comprehensive package of benefits including paid time off.
• Medical/dental/vision insurance.
• 401(k) to eligible employees.
• Participation in long-term incentive programs.