As part of the temporary workers, we are looking for an international pharmaceutical company in Penzberg for a Product Project Manager (m/f/d).
- Support Technical Regulatory Teams and Technical Regulatory Leads in developing charters, plans, detailed schedules, deliverables lists, status updates, resource requests and program specific communications for individual programs in the regulatory product portfolio. Be a thought partner to TRLs and team members, facilitate and drive team discussions based on high-level program knowledge
- Provide project management support at any stage of the drug development lifecycle. Provide support of PTR Strategic Focus Areas and cross-organizational initiatives
- Coordinate and facilitate meetings and all aspects of program information management ensuring robust documentation and communications
- Partner with TRLs and 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 platforms
- 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
- Maintain linkage between TRT and TDT or TPT ensuring alignment of assumptions and communications at all times
- Facilitate regulatory program risk assessment and align with TPM and TDT processes. Develop, execute and report on risk mitigation or issue resolution activities.
- Proactively monitor timelines, submission process KPIs, critical path and resources for assigned products using appropriate tools, project management principles and practices. Monitor timeline deviations from baseline and KPIs and closely collaborate with TRLs and Submissions Leads to keep submissions on track
- Provide support on major departmental and cross-functional initiatives including Strategic Focus Areas (SFAs).
- Develop and maintain the PPM resource library and improve it based on use and feedback
- Collaborate with Regulatory Operations and colleagues in PTR and PDR for regulatory submissions as needed
- BA/BS or MS in Scientific, Technical, Engineering or Business discipline
- A minimum of 8-10 years’ total work experience with at least 5 or more years’ relevant experience in project management within the pharmaceutical/ biotech/ medical device industry with a sound knowledge of drug development processes
- Project, Program, or Portfolio Management certification is preferred but not required
- Knowledge of Project Management methodologies, concepts, techniques and tools is required
- Prior experience with programs and portfolios in a strategic context is a plus.
- Prior regulatory experience preferred.
- Six Sigma or other OE-related certifications a plus
- Ability to travel up to 20%
What we offer
- A responsible job in a reputable pharmaceutical company
- Attractive income, according to your education and experience
- Working hours: 40 hours per week or part-time
- Personal assistance from your office headwaypersonal Penzberg
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