Role Summary
In this strategic and operational role, you will partner with Global Regulatory Affairs and Strategy (GRAAS) Strategic Planning and Operations (SPO) Sr Managers to provide flexible, high-impact support across Amgen’s Regulatory Affairs organization, driving department goals and initiatives and collaborating cross-functionally. Your primary focus is to support the Biosimilars and General Medicine therapeutic area VP and teams, and the Global Regulatory Policy & Intelligence (GRPI) AVP and teams, ensuring effective planning, governance, communication, and execution of priorities. The Senior Manager, Strategic Planning & Operations, serves as a strategic and operational partner to senior Regulatory leadership.
Responsibilities
- Translating strategic priorities into executable plans
- Driving operational excellence
- Enabling effective decision-making
- Proactively identifying and resolving risks and issues
- Identifying operational objectives
- Developing and maintaining business relationships across GRAAS and partner organizations
- Owning and evolving the operational prioritization, governance, and execution framework for supported leadership teams
- Partner with the VP of Biosimilars & General Medicine and AVP of GRPI to define, operationalize, and track strategic priorities and annual objectives
- Translate leadership goals into clear operating plans, milestones, and deliverables across multiple teams
- Act as a trusted advisor and thought partner to senior leaders on strategy, execution risks, and organizational effectiveness
- Drive business performance management, including tracking KPIs, progress against commitments, and identifying risks and mitigation strategies
- Support governance forums and team meetings including agenda development, facilitation, decision documentation, and follow-up
- Design, facilitate, and support key face-to-face meetings including agenda preparation and partnering with facilities and administration teams on all logistics
- Support budgeting, resource planning, and organizational planning activities as needed
- Own and maintain an integrated view of priorities, commitments, and dependencies across Biosimilars, General Medicine, and GRPI
- Facilitate prioritization and trade-off discussions, surfacing capacity constraints, risks, and cross-team impacts
- Proactively identify misalignment between strategic priorities and operational execution, and recommend course corrections
- Serve as the central point of coordination for re-prioritization in response to emerging regulatory, policy, or business changes
- Develop and execute leadership communication plans, including all-staff meetings, leadership updates, and executive-level presentations
- Facilitate preparation, archiving and distribution of internal communications, reports, and presentations
- Build and maintain strong partnerships with key stakeholders across GRAAS, R&D, Finance, HR, and other functions
- Manage and implement daily assigned tasks as requested
Qualifications
- Required: Doctorate degree and 2 years of related experience; or Master’s degree and 4 years of related experience; or Bachelor’s degree and 6 years of related experience; or Associate’s degree and 10 years of related experience; or High school diploma / GED and 12 years of related experience
- Preferred: Strong verbal / written communication skills, including listening & presentation skills
- Preferred: Strong problem-solving skills
- Preferred: Strong interpersonal and organizational skills, ability to effectively work the matrix
- Preferred: Ability to establish trusted partnerships with colleagues at all levels
- Preferred: Ability to successfully prioritize a diverse workload to meet deadlines, and leadership expectations
- Preferred: Ability to work effectively as a member of a diverse team, building appropriate relationships and maintaining confidentiality
- Preferred: High degree of flexibility, adaptability, accountability, and professionalism
Skills
- Advanced project and program management experience, including oversight of complex deliverables, timelines, and stakeholders
- Basic understanding of the pharmaceutical/biotechnology industry, with emphasis on Regulatory Affairs or Research and Development
- Knowledge to represent and evaluate strategies and to critically evaluate advice
- Knowledge of continuous improvement principles
- Experience writing and presenting clearly to Senior leadership audience