Director, Strategic Medical Writing

Role Overview

• Provides strategic 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 people leader(s) and multiple individual contributors located in geographically dispersed locations with oversight of both internal and external staff.
• Ensures effective management of external business partners such as CROs who are employed to deliver clinical documents according to established standards and processes.
• 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 a large number of 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.
• Maintains expert knowledge of US and international regulations, requirements, and guidance associated with preparation of regulatory documentation.

Requirements

• Bachelor's Degree or higher required; scientific discipline preferred.
• A minimum of 10 years of bio-pharmaceutical industry experience in a global pharma, biotech, life science, or healthcare authority delivering medicines/therapies to a broad market across various therapeutic areas.
• In addition, minimum of 5 years of people management experience.
• 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
• eligible to participate in long-term incentive programs