Director, NORAM Medical Affairs Operations

The Director, NORAM Medical Operations Director plays an integral role in overseeing and coordinating the department's core functions, with a focus on organizational efficiency, communications, project management, contract management, budget oversight, and coordination of medical training, medical education and communication of medical evidence. The Director, NORAM Medical Operations is a strategic and operational leader responsible for enabling high-performing Medical Affairs (MA) functions within bioMerieux. This role oversees team training and capability building, develops and maintains standard operating procedures (SOPs), drives medical strategy execution, oversees departmental budgeting, and implements continuous process improvements to ensure operational excellence.

The Director serves as a key partner to Medical Affairs leadership, ensuring scientific, clinical, and operational alignment across programs and functions. The Director, NORAM Medical Operations is the owner of key departmental projects and leads the Medical Affairs Operations Team, partnering closely with other critical stakeholders at bioMerieux, including compliance, finance, legal, quality, purchasing, marketing, external vendors, as well as Global Medical Affairs. This is a key strategic role, defining and supporting necessary projects related to education, evidence, insights, and customer engagement.

Primary Duties

• Supports the development, alignment, and implementation of short-term and long-term strategic goals to achieve operational excellence and meet deliverables. Partners with Medical Affairs leadership to develop, operationalize, and continuously refine the Medical Affairs strategy across therapeutic, diagnostic, and regional portfolios, helping to translate strategic objectives into actionable project plans, KPIs, and timelines that support scientific engagement, evidence generation, and medical education goals. Oversees and ensures the quality of the departmental strategic planning processes, including operations tasks, and other activities related to pipeline and established products and assets. Leads organization, updating and communication of strategic plans to stakeholders.
• Leads Quality Initiatives and Governance. Develop, maintain, and update Medical Affairs SOPs, work instructions, and quality documentation to support compliant, efficient, and consistent operations. Implement and refine operational governance frameworks for scientific review, medical communication standards, congress planning, evidence generation processes, and partnership evaluation. Ensure SOPs align with regulatory requirements, industry best practices (e.g., IVD, CLIA, CAP guidelines), and corporate quality management systems. Elevates business processes through close collaboration with Compliance, Regulatory, and Legal counterparts. Ensures material development for internal and external use is aligned with organizational goals and priorities, meets compliance, regulatory, and legal requirements.
• Leads Continuous Process Improvement. Leads ongoing evaluation of Medical Affairs business processes to identify efficiency gaps, operational risks, and opportunities for automation or streamlining. Implement process improvement methodologies to enhance program execution, documentation, and cross-functional workflows. Introduces toolkits and templates (ASANA) to standardize reporting, project management, communication, and scientific planning activities.
• Coordinates Financial Planning and Budget Management. Establish and oversee project management frameworks for all MA initiatives, including medical launches, clinical collaborations, evidence-generation programs, and scientific communication outputs. Monitor timelines, risks, and deliverables; provide transparent reporting to leadership on progress and resource needs. Coordinates cross-functional project teams to ensure timely execution and integration of medical insights into decision-making.
• Coordinates Medical Education, Medical Training, Onboarding and Development. Oversees Medical Education initiatives aligned with organizational priorities. Designs and leads a structured Medical Affairs training and competency development program, ensuring team members remain knowledgeable on clinical evidence, diagnostics technology, healthcare policy, and compliance requirements. Oversees onboarding programs for new hires, ensuring consistent integration into MA processes, systems, and scientific platforms. Identifies upskilling needs; partnering with HR/L&D to implement development plans, mentorship programs, and performance-support resources.
• Perform all work in compliance with company quality procedures and standards.
• Performs other duties as assigned.

Experience

• Bachelor's degree in life sciences, public health, or business required
  • Advanced degree strongly preferred
• 8+ years of experience in Medical Affairs, Clinical Affairs, or Operations roles within the diagnostics, medtech, or biotech industry including 3+ years of specific professional Team Management experience
• 4+ years practical experience in US healthcare environment preferred

Knowledge, Skills & Abilities

• Proven leadership in medical operations, project management, process improvement, and staff development.
• Strong understanding of diagnostic technologies, evidence generation approaches, healthcare decision-making, and compliance frameworks.
• Exceptional skills in communication, cross-functional collaboration, budget management, and organizational planning.
• Demonstrated success with development, implementation, and management with strategic planning.
• Advanced knowledge of compliance, legal, and regulatory guidelines for medical support of IVD solutions.
• Advanced knowledge of best practices for partnership with 3rd party medical education providers.
• Advanced knowledge of budget management, including development, monitoring and forecasting.
• Demonstrated capabilities in the following areas:
  • Strategic planning and execution
  • Quality orientation and compliance mindset
  • Operational excellence and process optimization
  • Operational excellence and process optimization
  • Team leadership, training, and coaching
  • Cross-functional communication
  • Change management

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BioMerieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMerieux's or its affiliates' application process by contacting us via telephone at (385) 770-1132, by email at [emailprotected], or by dialing 711 for access to Telecommunications Relay Services (TRS).