Project Manager I

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


BioMarin Global Regulatory Affairs is responsible for obtaining approval for new BioMarin products and ensuring that approval is maintained throughout the product lifecycle. Regulatory Affairs serves as the interface between the regulatory authorities and the program teams aiming to ensure that the project plan correctly anticipates what the regulatory authority will require before approving the product. It is the responsibility of Regulatory Affairs to keep abreast of current legislation, policies, guidelines and other regulatory intelligence. The Regulatory Affairs department plays an important role in giving advice to the program teams on how best to interpret the regulatory legislation and guidelines.


 


As part of the Regulatory Affairs department, the Regulatory Project Management (RegPM) team is responsible for ensuring regulatory strategies are translated into realistic and achievable submission plans and that Global Regulatory Team operations are driven by effective application of project management expertise.


 



Project Manager 1/2 supports and drives the efficiency and effectiveness of the Global Regulatory Team, Regulatory Strategy Meetings, and Regulatory or cross-functional sub-teams such as Health Authority meeting teams or Marketing Application/Investigational New Drug/Clinical Trial Application filing teams, as appropriate, in partnership with the Global Regulatory Lead or team lead through meeting management, timeline development / management / tracking, and cross-functional communications.


 

Skills



    • MS Project experience (or other project planning software) preferred

    • Proficiency in MS Office suite, including Outlook, Word, and PowerPoint, and Excel required




COMPETENCIES:


 


Project Manager 1 position requires foundational decision-making, communication and strategic thinking skills as well as proficiency in influencing others and working on cross-functional initiatives.


  


Regulatory Affairs Core Competencies:



    • Decision Making and Problem Solving, such as analyzing, evaluating, and suggesting possible solutions to problems consistent with procedures and within sphere of influence

    • Influence, Cross-Functional Collaboration and Organizational Awareness, including demonstrating an understanding of organizational structure, key decision-making processes and governance and communication channels

    • Agility and Proactivity, such as skill in inspiring, motivating and empowering employees by expecting high standards of performance while giving latitude, offering encouragement, and expressing confidence

    • Leadership, such as taking accountability for own team assignments and proactively offering support to team members and team leaders when appropriate

    • Communication, such as developing and delivering well organized and effective presentations

    • Strategic Thinking and Planning, including demonstrating an understanding of Global Regulatory and BioMarin strategic objectives

    • Project Management, such as demonstrating a basic understanding and use of project management principles, tools, and techniques, including MS Project

    • Team and Stakeholder Management and Communication, including an ability to leverage relationships to influence timelines and project management outcomes across the business

    • Drug Development and Product Knowledge, including understanding the objectives/purpose of each clinical trial phase

    • Regulatory Guidances and Processes, such as having a comprehensive understanding of the regulatory pathways, including when and how to file for designation, the time points and opportunities for interaction, and the resources required

    • Process Improvement, including an ability to effectively leverage data for process improvement using an extensive knowledge of data and statistical analysis and able to clearly communicate results and implications


Education



    • Bachelor's degree in health or life sciences

    • 4+ years experience with bachelor’s degree

    • Project Management experience in Biotech/Pharmaceutical company preferred

    • Regulatory Affairs experience in Biotech/Pharmaceutical company preferred


 
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.