Senior Specialist, Regulatory Strategic Planning. Job in North Chicago LilyLifestyle Jobs

Senior Associate, Regulatory Strategic Planning The Senior Associate, Regulatory Strategic Planning, is responsible for successfully delivering project management capabilities for cross‑functional teams within 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 supporting process improvement efforts to help achieve business performance goals for regulatory compliance and productivity. Responsibilities Provides project management leadership in support of GRPTs; develops schedules and wave plans to ensure regulatory milestones are adequately planned and tracked, and works with Regulatory staff across the globe to drive the execution of GRPT‑related activities and deliverables. Works independently to plan and facilitate GRPT and related meetings (e.g., Dossier Kick‑off Meetings, Regulatory Strategic Reviews, Rapid Response Teams, and Regulatory Advisory Panels); ensures action items are assigned and completed; periodically summarizes and shares team highlights with stakeholders as necessary. Interacts with ADTs and other key stakeholders across the enterprise to ensure regulatory milestones are properly communicated; periodically communicates with Regulatory management to provide timely updates on progress and/or issues that may impact the global program. Drives GRPT operations in support of the Global Regulatory Lead (GRL); ensures GRPT‑related information and tools (e.g., team sites, rosters, charters, schedules) are kept up to date. Executes process improvement initiatives of low‑to‑medium complexity; demonstrates effective change leadership, and is able to move ideas from concept to implementation. Possesses working knowledge of the regulatory product lifecycle, business processes, and regulations across Regulatory sub‑functions; is able to provide business subject‑matter knowledge on assigned initiatives, and demonstrates effective problem solving & decision making, learning and adjusting behaviors based on prior results/experience. Leads team meetings effectively; uses the project governance process to effectively escalate and drive resolution of issues; demonstrates effective group facilitation skills and ability to drive consensus among team members regarding process changes. Develops effective working relationships with project team members; prepares and delivers clear, relevant, and influential written reports and presentations for a variety of audiences. Develops effective working relationships with project team members; prepares and delivers clear, relevant, and influential written reports and presentations for a variety of ordinates and drives deliverable preparation; develops and maintains process models using standard methods and tools; manages and tracks budgets, contracts, communications, metrics, and reporting‑related processes. Supports mechanisms to identify, capture, and report business performance metrics. Analyzes metrics with subject‑matter experts in an effort to drive increase compliance, quality, and productivity across the organization. Incorporates diverse, cross‑functional, and global perspectives into strategies & tactics that consistently enhance the ability to improve outcomes for the Regulatory Affairs organization. This position will work a hybrid work schedule (3 days in office) from our Lake County, IL AbbVie headquarters. Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) is required. Qualifications Required Experience 3 years’ related experience Proven leadership skills and presence, experience working in a complex and matrix environment Strong verbal and written communication skills, ability to work with cross‑functional teams Ability to manage a budget and forecast financial requirements, strong attention to detail and problem‑solving skills Ability 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 Preferred Experience 3 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 Education Required Education Bachelor’s degree in science (biology, chemistry, microbiology, medical technology, pharmacy, pharmacology), math, engineering, business management, or medical field Preferred Education Certifications such as RAC from the Regulatory Affairs Professionals Society, and/or Project Management Institute (PMI) Project Management Professional (PMP) are a plus Additional Information This role is a hybrid schedule (3 days in office) and located in Lake County, IL. The compensation for this role is $78,500. 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 short‑term incentive programs. 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. #J-18808-Ljbffr United Cerebral Palsy of Georgia