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Posted Apr 5, 2026

Associate Director, Regulatory Strategic Writing

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Job Description: • 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. • 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. Requirements: • A minimum of 8 years of bio-pharmaceutical industry experience in global pharma, biotech, life science, or healthcare authority delivering medicines/therapies to a broad market across various therapeutic areas. • Minimum of 2-3 years of people management experience. • Bachelor's Degree or higher required; scientific discipline preferred • Possesses broad knowledge and track record of successfully managing a clinical and regulatory writing group. • Proactively prepares for all possible document obstacles. • Demonstrated high level of competency in the AbbVie leadership behaviors. • Big picture and strategic thinker – can formulate a vision of future state and lead the organization to build tactical plans to achieve this. • Experience implementing large-scale change and process improvements relating to clinical and regulatory writing. • Builds relationships and gains cross functional alignment. • Experience with cross-functional leadership and a proven ability to influence and get things done within the intricacies of a highly matrixed organization. • Excellent business and financial aptitude, very analytical and uses data to drive the business and continuous improvements. • Experience leading scaled global teams; managing and developing talent; leader who is able to engage, inspire, and align large, diverse teams of seasoned professionals. Benefits: • paid time off (vacation, holidays, sick) • medical/dental/vision insurance • 401(k) to eligible employees • long-term incentive programs