Regulatory Affairs Business Operations and Processes Project Manager

Location:  San Rafael, California Category: Regulatory Employment Category: Fulltime-Temporary

Description

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives. 
 

Duties


SUMMARY DESCRIPTION


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. These activities may include, but not limited to:


•          Learning and development coordination and tracking,


•          Process improvement and procedures tracking and management,


•          Technology implementation (metrics support and project tracking),


•          Document management special projects and on-going eDMS activities.


The successful candidate must be able to follow directions and multi-task on a wide variety of Regulatory business operations projects/tasks while simultaneously maintaining a high quality of work. 

Skills


RESPONSIBITIES


Regulatory Business Operations



    • Provide project management support for various Regulatory Business Operations activities including, but not limited to, process teams, Regulatory Business Operations Committee (RBOC), Document Management teams, and other business systems and processes within Regulatory Affairs and support for cross functional teams as assigned.

    • Monitor Regulatory Business Operations correspondence, responding to quires, providing receipt of new document into process, and escalating issues. 

    • Provide support for moving documentation through the procedure management system

    • Learn Regulatory processes and requirements across all Regulatory functions to be able to evaluate procedures for effectiveness

    • Implement initiative to consolidate department procedures, including, needs for revision, merging, or obsoleting procedures 

    • Implement process improvement and procedures tracking and management, identifying and executing efficiencies and tools

    • Coordinate RBOC and other process team meetings, develop and distribute agendas, capture and distribute meeting minutes, following up on and track progress on action items

    • Liaise and align with stakeholders in Regulatory Affairs and cross-functionally on status and activities

    • Project tracking and metric reporting on RBOC and technology projects


Training and Curricula Management



    • Learning and development coordination and tracking, and maintenance of training curricula

    • Evaluate Regulatory training curricula for appropriate assignment for Regulatory functions by learning Regulatory processes and procedures identify any misalignment

    • 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


 


Documentation Management System Project Support



    • 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


 

Education



COMPETENCIES


The incumbent demonstrates foundational core competencies across communication and collaboration and adaptability and flexibility.  For example:



    • Demonstrates the ability to distribute accurate information but may need guidance in appropriately crafting messages for target audience

    • Responds promptly to stakeholders, peers and management with clear and organized written and/or oral messages

    • Takes accountability for own team assignments and proactively offers support to  team members and team leaders when appropriate

    • Embraces new challenges or changed priorities and adjusts plans and priorities accordingly


The individual in this position is expected to be demonstrating foundational technical competence in service delivery orientation, project management, process management and systems, reporting and governance. For example:



    • Builds and maintains effective working relationships with Regulatory Affairs functional customers by responding in a timely manner and following through on commitments



    • Clear, concise oral & written communication

    • Looks for best practices that can be leveraged in solution development

    • Experience in electronic document management, project management and/or learning and development

    • Excellent oral and written communication skills

    • Can identify best practices that can be leveraged in solution development

    • Possess strong computer and Internet skills, such as electronic document management systems, project management tools, SharePoint/Office365, Power BI, , and e-conferencing platforms.



    • Exhibits a solid understanding and independent execution of project management principles, tools, and techniques



    • Demonstrates familiarity with common process improvement tools and methodologies such as process mapping, root cause analysis and accountability/responsibility mapping

    • Thrives in an environment of cross-functional interaction and collaboration by highlighting interdependencies



    • 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

    • Familiar with project management methodology and process



    • Expert in Microsoft Office (Outlook, Excel, Word, & PowerPoint)

    • Embraces new challenges or changed priorities and adjusts plans and priorities accordingly


 


Education



    • 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

 
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.