This is a 10-36 months contract role @Genentech in South San Francisco, CA. W2 ONLY NO 3RD PARTIES
- Serves as Project Manager for on-going release management for Regulatory system.
- Serves as the lead project manager representing the business functions on an initiative to assess the scope and usage of our tools as well as managing certain operational activities, such as change request review and prioritization for the current solution, planning for future release and managing those releases.
- Represents the Regulatory business function(s) at project level and tracking business focused deliverables in the assessment, planning, and implementation of systems and tools based on business processes and business needs.
- Provides business project / initiative oversight, during planning, development, execution and closeout of project work, and project management methodology expertise.
- Proactively evaluate and plan for deployment, training, communication and other change management. In addition, plan for transition to maintenance phase/operations and create high-level maintenance plan with sponsor/business lead.
- Project Managers are expected to independently manage complex projects across multiple platforms adapting specific tools, templates, and business process in these areas. Project Manager may be assigned to any project within the portfolio and is expected to actively engage in project management related activities.
- Strong project management skills.
- The job will involve a high degree of strategic thinking.
- Looking for a top performer who can hit the ground running and can have immediate impact on our project.
- Ability to assess change requests from the user community and prioritize to prepare a release plan.
- Ability to influence with or without authority, facilitate groups with diverse perspectives, bring teams to consensus/alignment.
- Takes accountability for actions, drives results, learns from mistakes. Is direct and truthful and therefore widely trusted. Delivers of promises, goals, and expectations.
- Makes quality decisions and resolved problems rapidly.
- Ability to communicate effectively up and down, at all levels of the organization, teach and present complex and/or new ideas with clarity and simplicity.
- Excellent planning and prioritization skills with the ability to multitask and adapt. Able to synthesize large amount of information.
- Able to deliver results despite shifting environment.
- Ability to define problem statement clearly and accurately and apply structured and disciplined methodology to identify data-driven root causes.
- Innovative and effective in solution development, risk mitigation, and execution.
- Expertise in the drug development process.
- Knowledge of relevant regulatory requirements (e.g. FDA & EU) applicable to various stages of drug development, including cGMP.
- Experience with systems maintenance/improvements and systems integrations in support of business processes
- Good knowledge of Regulatory systems and processes
- Experience of influencing and negotiating at management level to achieve delivery
- Strong understanding of Information Systems
- Familiarity with SDLC
- B.A./B.S. in Scientific or related discipline with a minimum of 5 years experience in project management and the Pharmaceutical or Biotech industry is required. Advanced degree preferred.
- Qualified candidates must have a proven track record leading technology projects, supporting on the business side, and a strong technical knowledge of project management methodologies.
Skills: pmp, gmp.
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