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Strategic Planning & Operations Sr Mgr - General Medicine , Biosimilars & Regulatory Policy

Amgen
Remote friendly (United States)
United States
Operations

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