AbbVie

Director, Regulatory Portfolio Management

Employer
AbbVie
Location
Lake County, IL, United States
Posted
Feb 18, 2021
Ref
2102745
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines 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: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

The Director of Regulatory Portfolio Management leads a team of Regulatory Strategic Planers (RSPs) that support Global Regulatory Product Teams (GRPTs). Provides oversight for the development and implementation of project management activities supporting global strategies to obtain and maintain market approval for products. Combines knowledge of regulatory and drug development life cycles to drive cross-functional alignment, and collaborates with Therapeutic Area Heads to successfully support regulatory programs. Manages a portfolio of projects and operational activities that enable the identification, implementation, measurement, and enforcement of activities to drive regulatory compliance and process improvements.
  • Leads multiple cross-functional RQS projects to achieve business results. Leads one or more solution offerings, whether related to business strategy, project/program/portfolio management, Integration/Alliance Management, or related offering(s) provided as part of an internal RQS business consulting group.
  • Works independently in a role that demonstrates organizational influence within or across RQS functions. Transforms concepts into executable initiatives, and drives definition of project scope, timeliness and deliverables. Seeks input from and forges agreements among sponsors regarding initiative goals and objectives.
  • Leads or develops project proposals and cost estimates leveraging past experience in project management. Shepherds proposals to ensure appropriate prioritization within the RQS project portfolio. Facilitates staffing of business performance improvement initiatives including sourcing of external consultants and service providers.
  • Leads project teams effectively. Escalates and drives 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 each of the RQS business functions. Demonstrates knowledge of the product life-cycle, Regulatory, Quality and Safety business processes, and regulations in the RQS functions. Monitors execution of the business performance improvement portfolio for cross-RQS projects. Works with RQS management to develop long-term strategies for business performance optimization within RQS.
  • Develops compelling value propositions and business cases for proposed initiatives. Collaborates effectively with management, Subject Matter Experts (SMEs), Quality Systems and peers to design cross-functional solutions.
  • Effectively frames complex issues for decision-makers. Prepares and delivers effective management presentations that lead to actionable results.
  • Effectively manages across projects in the portfolio to ensure alignment and consistency with business strategy and to drive efficient allocation of resources.
  • Develops RQS cross-functional project proposals for the Long Range Planning (LRP) and budget planning efforts in support RQS function. Interacts with peers and stakeholders to drive efficient allocation of resources across related and partner functions such as IT and Finance.
  • Creates information sharing opportunities with RQS function project managers to help enhance business relationships, business consulting, project management, and process design skills across RQS.

Qualifications
  • Bachelor's degree required. Advanced degree preferred. Certification a plus. Project Management Institute (PMI) Project Management Professional (PMP) certification preferred.
  • Minimum 7 years project/portfolio management or related experience required. 5+ years in Regulatory Affairs, R&D Quality Assurance, or Safety functions preferred. 5+ years in pharmaceutical, healthcare or regulated industry preferred. Strong knowledge of pharmaceutical regulations, e.g., FDA and EMA and their impact to organization processes and technology tools preferred. Knowledge of Continuous Improvement/Lean Six Sigma concepts preferred.
  • Proven 5 years in a leadership role with strong management skills required. Experience serving as and managing business management consultants preferred.
  • Experience working in a complex and matrix environment required. Demonstrated ability to lead multi-divisional and multi-functional teams with global aspects required. Mastery level experience facilitating process modeling and redesign initiatives preferred. Substantial experience facilitating process modeling and redesign initiatives preferred.
  • Strong communication skills, both oral and written required. Ability to craft compelling business cases and sell new ideas preferred.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Keyboard use (greater or equal to 50% of the workday)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
D
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.