Project Manager IV
One DNA Way South San Francisco, California 94080 | Contract
Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world' s leading biotech companies, with multiple products on the market and a promising development pipeline.
Job Title: Senior Project Manager/Project Manager
GENERAL ROLE SUMMARY/PURPOSE:
This Technical Regulatory Project Manager (PM) 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). The Technical Regulatory Project Manager is a strategic thought partner with the TRL and TRT team members, an advocate of the PMO, utilizing best practice methodologies to support TRTs and providing clear communications to the PMO and their teams for assessment and trending at the portfolio level.
This role builds effective relationships with Technical Regulatory Leads (TRLs), TRT Members, Product PMO, Technical Development Teams, Technical Product Teams, and other program stakeholders to ensure visibility to TRT operations and cross-functional alignment of TRT strategy. The Technical Regulatory Project Manager may act as a single point of contact for a TRT, second only to the TRLs, the primary accountable leaders of TRTs.
- 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 effectively facilitate TRT meetings and all aspects of program information management ensuring robust documentation and communications
- Strong thought 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
- Ensure alignment of regulatory strategy and compliance across the Biologics and Small Molecule platforms, support multiple products and resolve issues impacting regulatory projects
- 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
- Monitor critical path timelines and resources for assigned products using appropriate tools, principles and practices to deliver projects successfully on time. Collaborate with Program Managers from cross-functional teams as necessary (TDT, TPT, RAFT etc.)
- Provide support to the Product PMO and to the PTR site management on major departmental and cross functional initiatives and collaborate effectively with other Project and Portfolio Management Groups
- Leverage and continuously improve Product PMO business process and program management methodologies and support with budgeting and resource planning
- Develop and maintain the PMO g-site, resource library (templates, tools etc.) and improve it based on feedback by the TRTs and other users
- Collaborate with Regulatory Operations and colleagues in PTR and PDR for regulatory submissions as needed
- Train less experienced PTR colleagues in the principles of Project Management and establish simple project management processes for early stage products
- BA/BS in Scientific, Technical, Engineering or Business discipline. Advanced degree a plus.
- A minimum 8+ years’ total work experience within the pharmaceutical/biotech industry with at least 3 years relevant project management experience
- Sound knowledge of drug development processes with at least 3 or more years’ relevant experience in project management within the pharmaceutical/biotech industry with a sound knowledge of drug development processes
- Project, Program, or Portfolio Management certification is preferred; Knowledge of Portfolio and Program Management methodologies, concepts, techniques and tools is required
- Prior experience managing portfolios in a strategic context is a plus
- PMP Certification preferred
- Prior regulatory and CMC experience a plus
- Six Sigma or other OE-related certifications a plus
- Highly Competent in MS office applications including Excel, Power Point, Word, Project, etc.
- Proven abilities to effectively lead, organize and prioritize project activities to drive deliverables
- Strong influencing skills; consistently achieves targeted results without authority and by leveraging his/her expertise, business knowledge, interpersonal skills, strategic insights, and organizational savvy
- Strong partnering skills; has exceptionally strong and highly effective working relationships with internal and/or external customers and stakeholders
- Excellent interpersonal and organizational skills, including understanding of key change management concepts and methodologies
- Ability to lead cross-functional teams. Must work well as member of a diverse team and in a proactive, positive and collaborative manner
- Outstanding project management, planning, organization and time management skills. Can effectively and efficiently manage and complete multiple, large-scale and complex priorities and projects on-time and on-target
- Demonstrates Roche Values and Core Competencies
- Able to deal with ambiguity and constant change
- Able to work independently with minimal supervision
- Able to function effectively in a fast-paced, multi-tasking environment
- Knowledge of regulatory requirements, manufacturing or technical development processes, cGMPs or compliance experience a plus
- International or global business experience and working effectively across cultures preferred