Regulatory Affairs Business Operations & Processes Project Manager

San Rafael, CA 94901

Posted: 05/18/2020 Employment Type: Contract Industry: Clinical & Scientific Job Number: 17496

Job Description


Bayside Solutions is seeking a Regulatory Affairs Business Operations & Processes Project Manager 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.

 

Regulatory Affairs Business Operations & Processes Project Manager

 

Job Benefits:
  • 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:
  • The Regulatory Affairs Business Operations and Processes (RBOP) Project Manager will support the Regulatory Affairs department worldwide on management of procedures, processes, technology, and learning and development.
  • Generate and distribute periodic reports and metrics regarding Regulatory procedures development and training performance for Global Regulatory Affairs to Associate Director of RBOP and Reg Leadership as directed Collaborate with Regulatory functions, DSQ/Quest group to manage and update the global training curricula as needed.
  • Support training activities within Regulatory Affairs on document management, processes and policies, which may include, but not limited to, preparation of training materials, supporting live training sessions, set up of training rooms (in person and virtual).
  • Support the development and integration of Regulatory Affairs New Hire onboarding processes and procedures, which may include, development/revision of on-boarding forms/templates, supporting hire managers with new staff on boarding requirements and training and system set up.
  • Support electronic Document management projects within Regulatory Affairs as assigned Assist with data migration activities for a new Document Management System (eDMS).
  • Support document management process development teams including tracking of action items and follow up with SMEs on deliverables and timelines as assigned.

 

Summary of Qualifications:
  • BA/BS or higher in Biology, life or health sciences or related field preferred.  Certificates or other education in Project Management, Regulatory Affairs or Regulatory Science a plus.
  • 3+ years of relevant work experience in in Regulatory Affairs / Biotechnology or Pharmaceutical industries or relevant comparable background.
  • Thrives in an environment of cross-functional interaction and collaboration by highlighting interdependencies.
  • Demonstrates familiarity with common process improvement tools and methodologies such as process mapping, root cause analysis and accountability/responsibility mapping.
  • Exhibits a good understanding of general quality assurance concepts and practices.
  • Highly organized with a strong attention to detail Successful history of solving problems of moderate complexity.
  • Proven ability to manage both day-to-day operations, as well as project work in a fast-paced environment.
  • Expert in Microsoft Office (Outlook, Excel, Word, & PowerPoint).

Meet Your Recruiter

Allison Glogovac

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