Our client is a global leader within the Pharmaceutical Industry. On behalf of our client, Swisslinx is currently looking for a Senior Project Manager to join a 1 year contract in Basel area.
Tasks & 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 including large molecules, small molecules, devices, antibody drug conjugates.
- Provide project management support to TRTs at any stage of the drug development lifecycle.
- Coordinate and facilitate TRT meetings and all aspects of program information management ensuring robust documentation and communications.
- Partner with TRLs and teams, 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 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.
- Provide support to PPM and PTR management on major departmental and cross-functional initiatives including Strategic Focus Areas.
- 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.
- 8+ years of experience in project management in pharma
- Excellent regulatory knowledge and experience
- Excellent understanding of drug development and CMC
- Bachelor's degree in Science, Technical, Engineering or Business discipline.
- Prior experience with programs and portfolios in a strategic context is a plus.
- Knowledge of agile methodology is highly desired.
The perfect candidate is an experienced project manager with drug development and regulatory knowledge. This person should have strong interpersonal skill as to be able to lead without direct authority. He/She will oversee complex programs and regulatory submissions projects.