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Manager, Global Medical Affairs Operations

Location San Rafael, California
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.

OVERVIEW:

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.

SUMMARY DESCRIPTION

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. 

KEY RESPONSIBILITIES:

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

  • Manage / facilitate annual business planning process and the development of Medical Plans and budgets
  • Create and manage tools for tracking and reporting on cross-functional team activities (as outlined in Medical Plans)
  • Facilitate the identification of risks and management of issues; ensure follow-up, proper escalation and resolution
  • Manage and report cross-functional team / Product Budget
  • Liaise and align with Project Managers and stakeholders outside Medical Affairs on status and activities
  • Provide project management support: Schedule team meetings, develop and distribute agendas, align team members, capture and distribute meeting minutes and follow-up on actions
  • Manage systems and tools for planning and tracking Key Opinion Leader (KOL) activity
  • Manage Advisory Board planning process and budget in collaboration with Global Medical Lead and outside vendor.  Assist in the development of written work instructions of this process

Controlled Documentation & Compliancewire

  • Process Medical Affairs SOPs through the existing controlled documents systems and collaborate with the Quality function to maintain and improve this process
  • Report on controlled documents status for both internal and external stakeholders. Generate and distribute periodic reports and metrics
  • Lead the implementation of a CAPA process and other quality initiatives as needed for Medical Affairs
  • Assign SOP training in the GxP training system and collaborate with Global Directors, Quality and Compliance Training to manage and update the global training curricula as needed
  • Consult regularly with Medical Affairs functional leadership to maintain listing of core Compliancewire assignments organized by function and role
  • Serve as Medical Affairs Compliancewire subject matter expert
  • Set up and issue Compliancewire assignments for new hire onboarding or on ad hoc basis
  • Generate and distribute periodic reports and metrics regarding Medical Affairs Compliancewire performance

Cross functional projects

  • Contribute to cross functional improvement projects, as appropriate


COMPETENCIES

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:

  • Distilling complex issues to simple terms, while driving information dissemination up and down the organization to influence appropriate outcomes
  • Ensuring that team roles and responsibilities are clearly defined, understood, and fulfilled
  • Contributing to the development of a motivating team/work environment by upholding positive morale and encouraging high performance
  • Demonstrating an ability to recognize, understand, articulate and respond promptly to issues that arise, escalating as appropriate
  • Appropriately escalates potential issues, clearly communicating whether the escalation is informational or requires action

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:

  • Proactively identifies and addresses Medical Affairs functional customer concerns and needs and strives to provide consistent customer satisfaction
  • Demonstrates comprehensive knowledge of BioMarin finance, accounting, and procurement processes, systems and policies
  • Being recognized as an expert who can guide and mentor others in department finance process management tasks including cost center management, scenario planning, budget development, forecast development, variance analysis and accruals
  • Demonstrates expert knowledge of the various contract structures (fixed units, T&M, etc.) and the most effective application of them to meet the needs of the business from both a services and financial standpoint
  • Experience with and demonstrated proficiency with PM tools such as Office 365 Suite (MSTeams, Power BI); Quality systems (Veeva) and Enterprise systems (Oracle)

CAREER DEVELOPMENT

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.


PEOPLE MANAGEMENT

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.

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