Director, Strategic Medical Writing
AbbVie
4 months ago
Remote friendly (North Chicago, IL)
United States
Clinical Research and Development
The Director, Strategic Medical Writer 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.
Responsibilities:
- Directly leads people leader(s) and multiple individual contributors in geographically dispersed locations; oversees internal and external staff and manages external partners (e.g., CROs) for clinical document delivery per standards and processes.
- Participates in continuous improvement across Strategic Medical Writing best practices, processes, and performance; leads cross-functional initiatives.
- Uses project management tools/techniques to drive multiple projects; responsible for overall project management for a large number of projects simultaneously.
- Works with cross-functional teams to define project objectives, strategies, timelines, and milestones; coordinates writing activities/submissions and holds team members to tasks/deliverables.
- Collects appropriate metrics for assigned therapeutic area(s).
- Maintains expert knowledge of US and international regulations for regulatory documentation; serves as subject matter expert/liaison to ensure high industry standards; may consult in partnerships.
- Maintains inspection readiness; represents the organization in regulatory inspections and quality audits.
Significant Work Activity: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day) is required.
Qualifications:
- Bachelor’s degree or higher required; scientific discipline preferred.
- 10+ years bio-pharmaceutical industry experience in global pharma/biotech/life science/healthcare authority delivering medicines/therapies across therapeutic areas; 5+ years people management experience.
- Track record managing clinical and regulatory writing groups; proactively handles document obstacles.
- Demonstrated competency in AbbVie leadership behaviors.
- Strategic thinker; experience implementing large-scale change and process improvements for clinical/regulatory writing.
- Experience leading cross-functional teams in a highly matrixed organization; ability to influence and get things done.
- Excellent business/financial aptitude; highly analytical and data-driven.
- Experience leading scaled global teams and developing talent; can engage, inspire, and align large diverse teams of professionals.
Responsibilities:
- Directly leads people leader(s) and multiple individual contributors in geographically dispersed locations; oversees internal and external staff and manages external partners (e.g., CROs) for clinical document delivery per standards and processes.
- Participates in continuous improvement across Strategic Medical Writing best practices, processes, and performance; leads cross-functional initiatives.
- Uses project management tools/techniques to drive multiple projects; responsible for overall project management for a large number of projects simultaneously.
- Works with cross-functional teams to define project objectives, strategies, timelines, and milestones; coordinates writing activities/submissions and holds team members to tasks/deliverables.
- Collects appropriate metrics for assigned therapeutic area(s).
- Maintains expert knowledge of US and international regulations for regulatory documentation; serves as subject matter expert/liaison to ensure high industry standards; may consult in partnerships.
- Maintains inspection readiness; represents the organization in regulatory inspections and quality audits.
Significant Work Activity: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day) is required.
Qualifications:
- Bachelor’s degree or higher required; scientific discipline preferred.
- 10+ years bio-pharmaceutical industry experience in global pharma/biotech/life science/healthcare authority delivering medicines/therapies across therapeutic areas; 5+ years people management experience.
- Track record managing clinical and regulatory writing groups; proactively handles document obstacles.
- Demonstrated competency in AbbVie leadership behaviors.
- Strategic thinker; experience implementing large-scale change and process improvements for clinical/regulatory writing.
- Experience leading cross-functional teams in a highly matrixed organization; ability to influence and get things done.
- Excellent business/financial aptitude; highly analytical and data-driven.
- Experience leading scaled global teams and developing talent; can engage, inspire, and align large diverse teams of professionals.