Global Regulatory Project Manager I
770 Lindaro Street San Rafael, CA 94901
Bayside Solutions is seeking a Global Regulatory Project Manager I to be part of our client’ s team in San Rafael. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Global Regulatory Project Manager I
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
• Manage Global Regulatory Team operations, including facilitation of GRT and Regulatory Strategy meetings (schedule, prepare/distribute documentation and ensure action item follow-up; meeting facilitation and leadership often required).
• Create and maintain Regulatory timelines and ensure that they are functional, consistent and integrated to reflect cross-functional dependencies; create and maintain reporting dashboards for teams and management.
• Track submission preparation progress, including but not limited to post-marketing and annual reporting commitments, to ensure timely filing to health authorities.
• Document project milestones/deliverables and report progress against team, department, and corporate goals.
• Facilitate short and long-term planning activities.
• Analyze internal Regulatory Affairs and Project Management processes, identify opportunities for improvement.
• Coordination across multiple departments: Clinical Sciences, Global Project Management, Commercial, PharmSci, CMC/TOPS, Biostats, etc.
Summary of Qualifications:
• Bachelor' s degree required. Project Management Professional and/or Regulatory Affairs Certification a plus.
• 2-5 years of experience in a project management or scheduling environment; a minimum of two years of experience managing teams and team operations.
• Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
• Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Uses professional concepts and company' s policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
• Experience with MS Project 2010, or similar scheduling software, required or proven skill at adapting to new software/technology. MS Project Server experience helpful.
• Pharma/biotech or related industry experience required.
• Excellent interpersonal skills; adept at working as a part of an interdisciplinary team and skilled at negotiation and influencing others.