Sr Director/Director, Medical Affairs Operations & Governance
About The Position
The Director, Medical Affairs Operations and Governance is a senior Medical Affairs leadership role responsible for establishing, overseeing, and continuously improving the operational, governance, and compliance infrastructure that supports Medical Affairs activities across the organization. This role serves as the central point of accountability for Medical Affairs operational excellence, cross-functional processes, and regulatory compliance, including oversight of Medical Information and Pharmacovigilance activities, with the Director of Pharmacovigilance reporting directly into this position. The Director will partner closely with Medical Affairs scientific leadership, Clinical Development, Regulatory, Quality, Legal/Compliance, and Commercial teams to ensure Medical Affairs activities are executed efficiently, compliantly, and in alignment with global regulations and internal standards. This role is critical to enabling scalable growth, inspection readiness, and disciplined execution across multiple therapeutic areas and life-cycle stages.
Requirements
- Advanced degree preferred related to science/medical field
- Minimum 8 years of commercial pharmaceutical industry experience
- Minimum 5 years of specialty pharmaceuticals experience
- Ability to travel up to 5-10%
Nice To Haves
- Significant experience in pharmaceutical market, medical affairs and launch experience preferred
Responsibilities
- Establish and lead the Medical Affairs operational framework, including governance structures, standard operating procedures (SOPs), workflows, and oversight mechanisms across all Medical Affairs functions.
- Serve as the primary owner of Medical Affairs policies, SOPs, and work instructions, ensuring alignment with global regulatory requirements and internal compliance standards.
- Drive consistency, efficiency, and scalability of Medical Affairs operations across therapeutic areas and franchises.
- Oversee vendor selection, contracting, and performance management related to Medical Affairs operations and services.
- Provide strategic and operational oversight of the Pharmacovigilance function, with direct line management of the Director of Pharmacovigilance.
- Serve as a key Medical Affairs representative during health authority inspections, audits, and safety-related inquiries.
- Act as a central Medical Affairs leader for compliance oversight, ensuring adherence to FDA, EMA, and other global regulatory requirements.
- Maintain continuous inspection readiness for Medical Affairs and Pharmacovigilance activities.
- Identify operational and compliance risks and proactively implement mitigation strategies.
- Partner with Legal/Compliance to support training, monitoring, and issue management related to Medical Affairs activities.
- Serve as a key liaison between Medical Affairs and cross-functional partners including Clinical, Regulatory, Quality, Commercial, IT, and Finance.
- Enable Medical Affairs scientific leaders and field teams by providing clear operational guidance, tools, and processes that support compliant execution.
- Support onboarding, training, and capability development for Medical Affairs team members related to operations, governance, and compliance.
- Oversee Medical Affairs operational systems and platforms (e.g., medical information systems, PV databases, document management tools).
- Drive continuous process improvement initiatives to enhance efficiency, data quality, and transparency.
- Leverage metrics and dashboards to monitor performance, compliance, and operational effectiveness.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
No Education Listed
Number of Employees
51-100 employees
