Manager, Global Medical Affairs OperationsLocation San Rafael, California Apply
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.
BioMarin Global Medical Affairs Operations
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 Global Medical Affairs offers scientific and clinical expertise to post-marketing products through the direction and planning of medical communications, support of education and research, liaising with the medical community, response to incoming inquiries about Medical Affairs products and trials, and leadership of the execution of Medical Affairs trials.
Within BioMarin Medical Affairs, the Operations group is responsible for guiding Medical Affairs leadership in the optimization of operational strategy, policies and procedures in support of corporate strategies. This includes the integration and transition of new programs as it relates to Medical Affairs; guiding the implementation of new technology impacting Medical Affairs teams; working with Medical Affairs stakeholders to develop consistent policies, SOPs and work instructions; providing overall Medical Affairs direction and guidance and ensuring consistent communication across Medical Affairs and support functions.
The Manager, Medical Affairs Operations, is an essential position within Medical Affairs Operations focusing on leading day-to-day management activities across assigned Operational responsibility areas to ensure high quality deliverables and internal stakeholder satisfaction. The Manager, supports Global Medical Affairs by providing process management, administration, and support related to controlled documents, systems, and process improvement activities. The successful manager builds value, quality, and performance metrics into assigned functional responsibilities. The Manager will lead projects and working teams and must build and maintain successful working relationships within Global Medical Affairs and with cross-functional colleagues.
Responsibilities will include the management of a range of Medical Affairs operational areas, as delegated, which may include, but are not limited to:
Cross functional Medical Affairs Team Oversight and Project Management
Controlled Documentation & Compliancewire
Cross functional projects
A Manager demonstrates advanced competence in Communication, along with foundational skill in Leadership, Strategic Thinking and Planning, and Problem Solving and Decision Making. Skills include:
The Manager is also expected to demonstrate advanced technical competence in the areas of Service delivery orientation, financial process management and contract process management along with foundational project management skills. This includes:
BioMarin offers comprehensive career development programming, including guidance, targeted training opportunities, and mentorship programming. A career development pathway for Medical Affairs has been defined and is available to employees of BioMarin.
The Manager may have an opportunity to manage direct reports; actual number of direct reports may vary depending on business needs
EDUCATION AND EXPERIENCE
· BA/BS or higher in life or health sciences preferred. Certificates or other education in regulatory compliance or contact management preferred
· 5 years of relevant experience in finance and contract management, technology management, project management, and clinical trial management
· Some line management experience (0-1 years) 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.