Für unseren Klienten, ein global agierendes Pharma-/Biotechunternehmen mit Standort in Penzberg suchen wir ab sofort einen:
Product Project Manager (m/w/d)
Tasks and responsibilities
- 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
- Project management support to TRTs at any stage of the drug development lifecycle (early or late stage development, marketing authorization or post-launch marketed phases)
- Coordinate and facilitate TRT meetings and all aspects of program information management
- 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. Assist with driving data compliance and accuracy across the organization
- Provide support to PPM and PTR management on major departmental and cross-functional initiatives including Strategic Focus Areas (SFAs)
- Leverage and continuously improve PPM business processes and program management methodologies
- Develop and maintain the PPM resource library (templates, tools etc.) and improve it based on use and feedback by the TRTs
- Collaborate with Regulatory Operations and colleagues in PTR and PDR for regulatory submissions as needed
- Train and onboard peers and TRT members in the principles of Project Management and standardized processes for TRT operations
Profile
- BA/BS or MS in Scientific, Technical, Engineering
- Min. of 5 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
- Experience with programs and portfolios in a strategic context is a plus
- Regulatory experience preferred
- Six Sigma or other OE-related certifications a plus
- Consistently achieves targeted results
- Understands key change management concepts and methodologies
- High level knowledge of regulatory requirements, manufacturing or technical development processes.
- Highly Competent Project and Smartsheet or other PM tools
Könnte dies Ihre nächste Herausforderung sein? Ich freue mich auf Ihre Bewerbung!
Thomas Jin
Scientific Talent Acquisition Specialist - Kelly Scientific Resources
089 384 090 7
thomas.jin[at]kellyservices.de
About Kelly
Kelly Services ist Ihr Spezialist für die Vermittlung von Fach- und Führungskräften. Wir bringen Sie mit genau dem Unternehmen zusammen, das zu Ihnen passt. Eine Vermittlung über uns ist persönlich, vertraulich und unkompliziert.
Unser Versprechen
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