Director, Strategic Medical Writing

Summary

Join AbbVie as a Director, Strategic Medical Writing and lead a centralized clinical writing function across therapeutic areas. You will oversee the creation of high-quality, submission-ready documents, manage the clinical writing process, and lead a team of internal and external staff. Responsibilities include strategic leadership, project management, cross-functional collaboration, and ensuring compliance with regulations. The ideal candidate will have extensive experience in the biopharmaceutical industry, strong leadership skills, and a deep understanding of regulatory requirements. This role offers remote work flexibility and a comprehensive benefits package.

Requirements

• A minimum of 10 years of bio-pharmaceutical industry experience in a global pharma, biotech, life science, federal agency organization delivering medicines/therapies to a broad market across various therapeutic areas
• Minimum of 5 years of people management experience
• Bachelor's Degree or higher in a scientific discipline
• Broad knowledge and track record of successfully managing Medical Writing operations and can proactively prepare for all possible document obstacles
• Demonstrated high level of competency in the AbbVie leadership behaviors (enter 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 medical Medical 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 of leaders who is able to engage, inspire and align large, diverse teams of seasoned professionals

Responsibilities

• Provides strategic leadership and direction for clinical and regulatory writing projects for one large or multiple smaller compounds within a therapeutic area for the creation and revision of clinical and regulatory documents within budget, with quality, and in accordance with timelines with oversight of both internal and external staff
• Ensures clinical and regulatory development strategy are reflected in the documents
• Directly leads at least 1 people leader and multiple individual contributors. located in geographically disbursed locations
• 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 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
• Leads execution of cross-functional initiatives for Strategic Medical Writing
• Collaborates with Strategic Medical Writing leaders to develop and maintain a workforce strategy plans for future talent needs, support employee development, addresses retention, and succession planning
• Collects appropriate metrics for assigned therapeutic area(s), as established by the Medical Writing organization
• Maintains expert knowledge of US and international regulations, requirements, and guidance associated with preparation of regulatory documentation and serves as a company-wide subject matter expert and liaison for other functions to ensure the application of highest industry standards
• Learns and applies therapeutic area and product knowledge to scientific projects and business improvement projects
• May serve as a consultant/liaison in partnerships with other companies
• Maintains inspection readiness for assigned remit
• Acts as the organizational representative in regulatory inspections and quality audits

Benefits

• This role offers the flexibility to work remotely
• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• This job is eligible to participate in our short-term incentive programs
• This job is eligible to participate in our long-term incentive programs