Director, Strategic Medical Writing - Remote

Overview

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.

In Short

• Directly leads multiple contributors and manages external business partners.
• Implements improvements across medical writing best practices.
• Utilizes project management tools for multiple projects.
• Develops project objectives and coordinates activities on writing projects.
• Maintains expert knowledge of regulations for regulatory documentation.
• Acts as the organizational representative in regulatory inspections.
• Ensures inspection readiness for assigned remit.
• Collects metrics for assigned therapeutic areas.
• Engages and inspires large, diverse teams.
• Builds relationships and gains cross-functional alignment.

Requirements

• Bachelor's Degree or higher required; scientific discipline preferred.
• 10 years of biopharmaceutical industry experience.
• 5 years of people management experience.
• Experience managing clinical and regulatory writing groups.
• Strong leadership and strategic thinking skills.
• Excellent business and financial aptitude.
• Experience leading global teams.
• Proven ability to influence within a matrixed organization.
• Ability to engage and align diverse teams.

Benefits

• Comprehensive benefits package including medical, dental, and vision insurance.
• Paid time off for vacation, holidays, and sick leave.
• Eligible for long-term incentive programs.