Associate Director, Regulatory Strategic Writing
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Job Description
Associate Director of Regulatory Strategic Writing responsible for managing clinical and regulatory writing projects. Leading teams in a bio-pharmaceutical context at AbbVie.
Responsibilities:
- 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
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