Business Performance Senior Manager

The senior manager will lead workstreams for mergers, acquisitions, and licensing integrations (MAL) across all deal phases from a regulatory life cycle perspective.

They serve as the subject matter expert in cross-functional and business development forums. They continuously improve both the MAL operating model as well as supporting other process improvement activities across the GRAAS process infrastructure.

Roles & Responsibilities:

• Strategic Leadership & Execution
  • Represent GRAAS at cross-functional MAL and Business Development-related forums, providing strategic input and thought leadership
  • Form and lead sub-function teams for integration and licensing activities, ensuring alignment with strategic objectives
  • Drive strategic solutions to complex business problems, leading analyses and negotiations with key decision makers
• Lead Regulatory workstreams across all deal phases
  • Serve as Lead for all product licensing work, including integrations into and transitions out of Amgen
  • Closely partner with Regulatory Affairs (RA) Therapeutic Area Integration Project Lead and advise/instruct them on end-to-end process and details of planning and execution of acquisition integration
  • Act as their delegate as needed in cross-functional meetings
  • Assist with pre-deal close GRAAS due diligence
  • Develop and manage GRAAS integration workplan
  • Draft and manage any new controlled documents unique to the integration, such as Quality Integration PLANs and bridging process GDEs
  • Lead and manage cross-company controlled document mapping and disposition
  • Identify gaps and risks to integration
  • Work closely with the Information management and change management teams, to ensure system changes and effective adoption of the change
• Act as a Point of Contact and Subject Matter Expert
  • Serve as member of the Amgen Corporate Integration Management Team
  • Forming and leading the team for effective execution
  • Serve as SME with licensing company and schedule and facilitate cross-company meetings as required
  • Maintain MAL status documentation and QMS bridging documents, manage risks/dependencies, represent regulatory in integration forums for thought leadership
• Drive Continuous Improvement
  • Optimise the MAL resources for GRAAS, embedding best practices and compliance with corporate and departmental expectations
  • Lead other continuous improvement projects to support the GRAAS process infrastructure.
• Bachelors degree (scientific area) and 12 years of directly related experience