Associate Director, Regulatory Strategic Writing

AbbVie•North Chicago, IL

About The Position

About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube. The Associate Director of Regulatory Strategic Writing (RSW) is 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.

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.

Responsibilities

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.
Participates in continual improvement across Strategic Medical Writing best practices, processes, and performance.
Leads execution of cross-functional initiatives.
Collects appropriate metrics for assigned therapeutic area.
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.
Maintains inspection readiness for assigned remit.
May act as the organizational representative in regulatory inspections and quality audits.