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. 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. Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
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.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this postingbased on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more orless than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our long-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paidand may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puer