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Project Manager II
Ref No.: 18-04062
Location: Oceanside, California

Summary

We are seeking a proactive, communicative candidate who is looking for career advancement in the healthcare/biotech industry, and those who possess a passion for company products and the clients they serve. The Product Project Manager will utilize best practice methodologies to support the Technical Regulatory Team while providing clear communications to the PMO for assessment and trending at the portfolio level. The successful individual will possess key skills and knowledge in the areas of portfolio management, the drug development process, and strong interpersonal skills. If this describes you, please take a moment to apply for the opportunity to interview and become a part of a fun, supportive team and #8 on Fortune 500's best places to work!

Duties:
The Product Project Manager Position is dedicated to supporting Technical Regulatory Teams (TRTs) in managing programs efficiently and effectively and in executing regulatory activities. This role will be involved in all aspects of TRT operations, while maintaining a tight linkage to the PTR Product Portfolio Management Office (PMO).

  • Support TRTs and TRLs in developing TRT charters, plans, detailed schedules, deliverables lists, status updates, resource requests and program specific communications for individual programs in the regulatory product portfolio including large molecules, small molecules, devices, antibody drug conjugates.
  • Provide technical management support to TRTs at any stage of the drug development lifecycle (i.e. clinical /development, marketing authorization or post-launch marketed phases).
  • Coordinate and facilitate TRT meetings and all aspects of program information management ensuring robust documentation and communications.
  • Partner with TRLs and site management, facilitating team interactions and mobilizing teams to deliver successfully on the agreed objectives.
  • Execute project management activities to support products for global market applications and product life-cycle activities.
  • Support issue-specific multi-product impacting regulatory projects to ensure alignment of regulatory strategy and compliance across the Biologics and Small Molecule platform.
  • Ensure regular and meaningful project communications, including dashboards, reports and metrics, to enable timely information and analyses to key stakeholders and decision makers.
  • Ensure product information flows between TRT members to ensure transparency, informed decision making, and optimal alignment of all technical regulatory deliverables.
  • Facilitate regulatory program risk assessment and align with TPM and TDT processes.
  • Develop, execute and report on risk mitigation or issue resolution activities.
  • Monitor critical path timelines and resources for assigned products using appropriate tools, principles and practices to deliver successfully on time.
  • Leverage and continuously improve Product PMO business process and program management methodologies.
  • Train junior PTR colleagues in the principles of Project Management and establish simple project management processes for early stage products.

*Preferred Certifications:
*

  • Project, Program, or Portfolio Management certification is preferred
  • PMP Certification preferred.
  • Six Sigma or other OE-related certifications a plus.

Education and Required Qualifications:

  • BA/BS in Scientific, Technical, Engineering or Business discipline.
  • A minimum of 5 years' total work experience with at least 2 or more years' relevant experience in project management within the pharmaceutical/biotech industry.
  • A sound knowledge of drug development processes.
  • Knowledge of Portfolio and Program Management methodologies, concepts, techniques and tools is required. Prior experience managing portfolios in a strategic context is a plus.