Senior Manager, Program Management

Summary

Join AbbVie's Clinical Science and Patient Safety organization as a Project Manager in the Office of the Product Safety Team (PST). Partner with the PST Lead to shape strategic priorities, manage multiple Product Safety Teams across therapeutic areas, and drive implementation. Proactively support the PST Lead in framing safety issues, making decisions, and managing escalations to management and the Safety Review Board (SRB). Strengthen internal and external partnerships, and drive timely development of key PST deliverables. Support inspection/audit readiness activities. This remote or on-site position requires a BA/BS (nursing or pharmacy preferred) and at least 5 years of pharmaceutical experience with a strong understanding of the drug development process.

Requirements

• BA/BS (prefer nursing or pharmacy, or healthcare professional)
• Education in biological/medical science or healthcare professional (advanced degree preferred)
• At least 5 years’ pharmaceutical experience with a strong understanding of the drug development process. Experience in Pharmacovigilance preferred
• Ability to work independently, influence stakeholders, and present sound business strategies

Responsibilities

• In partnership with PST Lead, shape the PST strategic priorities and drive implementation by applying strong understanding of Therapeutic Area, regulatory requirements, signal management & project management to influence characterization of the compound/product safety & effectiveness profile. This responsibility will be accomplished through building strong and trusted relationship with the PST Lead and core team members
• In partnership with the PST Lead, manage multiple Product Safety Teams across multiple Therapeutic Areas. This includes meeting planning and facilitation, meeting minutes documentation and post- meeting/general team management activities. Increase meeting productivity and advance decision- making effectively through the application of strong skillsets in strategic thinking, influence, leadership, relationship building, proactive-ness, curiosity and active engagement
• Proactively utilize experience and knowledge to support the PST Lead in framing safety issues and making decisions. Anticipate possible outcomes of safety issues and provide guidance to the PST Lead so that he/she can be proactively prepared. Systematically analyze the impact of safety decisions and connect the dots across other decisions, discussions and actions across the organization. Communicate perspectives to PST Lead and recommend solutions
• In partnership with PST Lead, manage escalation of safety issues and decisions to management and Safety Review Board (SRB). Create escalation documentation (e. g. SRB presentations) and help prepare the PST Leads for discussions. Manage the close-out of SRB action items for assigned PSTs
• Support the PST Lead in strengthening internal partnership/influence and establish role as the company leader of safety issues related to their compounds/products. Identify new opportunities for the PST Lead to build relationships and present thought leadership to peers
• Support the PST Lead in strengthening external engagement/presence by providing recommendations on channels for expanding external engagement including topic ideas for publications, conferences to present at key industry relationships to develop, etc. Support the creation of content for external engagement activities
• Drive timely development of key PST deliverables by planning and facilitating productive working sessions to create deliverables; share perspectives; push the thinking to create robust deliverables, suggest improvements, and connect the dots
• Support inspection /audit readiness activities. Engage in supporting PST-related inspection/audit activities and CAPAs/commitments

Benefits

• Medical/dental/vision insurance and 401(k)
• Paid time off (vacation, holidays, sick)
• Short-term incentive programs
• Long-term incentive programs