AbbVie Manager, Regulatory Strategic Planning in North Chicago, Illinois
AbbVie (NYSE:ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie at https://twitter.com/abbvie on Twitter, Facebook at https://www.facebook.com/AbbVieCareers/ or LinkedIn at https://www.linkedin.com/company/abbvie/jobs .
The Manager, Regulatory Strategic Planning, is responsible for successfully delivering project management capabilities for cross-functional teams of low- to medium-complexity within and across the Regulatory Affairs organization. The individual combines knowledge of scientific, regulatory, and business processes to properly drive the execution of AbbVie’s regulatory strategies. Responsibilities include developing and managing the schedules, activities, and deliverables for the Global Regulatory Product Teams (GRPTs), interacting with key stakeholders, and leading process improvement efforts to help achieve business performance goals for regulatory compliance and productivity.
Identifies, plans, and executes initiatives across one or more RA sub-functions and related areas. Initiatives may span regulatory strategy and policy, regulatory content management, labeling, advertising & promotion, registration management, area & affiliate operations, and/or submissions operations.
Develops project proposals, cost estimates, and schedules leveraging past experience in project management. Shepherds proposals to ensure appropriate prioritization within the RA project portfolio. Facilitates staffing of initiatives including sourcing of external consultants and service providers.
Contributes to business planning efforts in support of the Regulatory Affairs function. Interacts with peers and stakeholders to drive efficient allocation of resources across related and partner functions such as IT, finance, and related business areas.
Leads project team meetings effectively; uses the project governance process to effectively escalate and drive resolution of project issues; demonstrates effective group facilitation skills and ability to drive consensus among team members regarding process changes.
Possesses a working knowledge of product life-cycle, business processes and regulations in one or more RA sub-functions.
Develops effective working relationships with team members; communicates and interacts effectively with project sponsors, and shares information regarding projects concisely and effectively to project stakeholders.
Helps implement a project management approach for initiatives; develops project plans in support of the project management approach.
Prepares status reports and dashboards using standard templates. Tracks risks and mitigation plans; tracks issues and facilitates resolution; schedules team meetings; establishes agendas, keeps minutes.
Facilitates business teams to develop current state and future state process models.
Coordinates and drives deliverable preparation; develops and maintains process models using standard methods and tools.
Required Education:- Bachelor’s degree in science (biology, chemistry, microbiology, medical technology, pharmacy, pharmacology), math, engineering, business management, or medical field
Preferred Education:- Advanced degree in science, math, business management, or engineering is preferred- Certifications such as RAC from the Regulatory Affairs Professionals Society, and/or Project Management Institute (PMI) Project Management Professional (PMP) are preferred
Required Experience:- 5 years’ related experience. Proven leadership skills and presence. Experience working in a complex and matrix environment. Strong verbal and written communication skills- Ability to interact with senior management and executives. Ability to work with cross-functional teams. Ability to manage budget and timelines of projects and resources within a program or department. Ability to manage a budget and forecast financial requirements
Preferred experience:- 3-5 years in pharmaceutical, healthcare or regulated industry- Proficient in project planning and management including successful implementation of business process initiatives- Experience facilitating process modeling and redesign initiatives- Training and/or experience with process modeling tools- Knowledge of Continuous Improvement/Lean Six Sigma concepts
Strong attention to detail and problem solving skills
Effective use of negotiation skills to resolve issues in cross-functional teams to ensure completion of assigned tasks
Keen awareness to cultural nuances; proven ability to work in a global environment
Ability to successfully interact with multi-divisional and multi-functional teams from across the globe
Significant Work Activities
Keyboard use (greater or equal to 50% of the workday)
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.