• Job Description

  Req#: R-214649

  The Project Management Office (PMO) coordinates and handles the Regulatory projects within the CSL portfolio. The primary goal the PMO is to standardize the procedures by which the Regulatory PM team carries out its projects. Through standardization, the various project Global Regulatory Affairs Strategy Teams (GRASTs) can apply reliable assumptions and methods to produce consistent submission-related results. The PMO will also manage data and reporting, train personnel, develop project management tools and establish methods for improving the efficiency of processes.

  Responsibilities:

  • Prioritizing projects in alignment with the broader organization's strategic goals including planning systems integration
  • Managing project resources and resolving resource-related issues
  • Maintaining, updating, and reporting project data to stakeholders
  • Maintaining the documentation for the Reg PM team
  • Overseeing progress on the organization's projects
  • Supporting the teams and PMs working on the projects
  • Maintains visibility to all stakeholders about project details including submissions, approvals, health authority interaction, and other relevant dependencies. Furthers visibility in support of communicating priorities, resourcing constraints, and risks between project teams and upper management and allows them to work together in devising solutions based on concrete data
  • Strives for efficiency by ensuring consistent approaches and development of project management best practices. Provides feedback to the R&D PMO, the Global Submission Management Process team, and GRAST teams to support continuous improvement
  • Closely collaborates with the functional and cross-functional project management teams including R&D PMO to identify areas of improvement and implement necessary measures
  • The PMO will aid in the Reg PMs development through training, mentoring, and coaching. Will help to hone project management skills and provide professional support. Advocates for compliant application of the Global Submission Management Process and accurate use of the systems related to it

  Education:

  Bachelor’s degree or equivalent in IT, Life Sciences or Business.

  An advanced degree (MSc, PhD, MBA) in IT, Life Sciences or Business, and PMP certification or equivalent is preferred.

  Qualifications:

  • 5+ years’ experience in the biotechnology or pharmaceutical industry (biologics regulatory experience and experience in a similar role preferred).
  • In-depth knowledge in drug development and manufacturing processes for pharmaceuticals (from a regulatory perspective).
  • 5+ years’ experience as a project manager leading cross-functional project teams in a matrixed, global environment, including those with complex technical, geographic, and/or regulatory elements.
  • Demonstrated experience in leading cross-functional teams and delivering projects to meet business objectives on time, within budget and with quality.

  Our Benefits

  We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

  About CSL Behring

  CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

  We want CSL to reflect the world around us

  As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

  Do work that matters at CSL Behring!

• About the company

  CSL Plasma operates one of the world’s largest and most sophisticated plasma collection networks, with more than 270 plasma collection centers in the U.S., Europe, and China.

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