USWM, LLC

Compensation

Full Description

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.   DUTIES AND RESPONSIBILITIES:   The following reflects management’s definition of essential functions for this job but does not restrict the tasks that may be assigned.   Management may assign or reassign duties and responsibilities to this job at any time due to reasonable accommodation or other reasons. * 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.   QUALIFICATIONS:  * Advanced degree preferred related to science/medical field * Minimum 8 years of commercial pharmaceutical industry experience * Minimum 5 years of specialty pharmaceuticals experience * Significant experience in pharmaceutical market, medical affairs and launch experience preferred * Ability to travel up to 5-10% The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.   PHYSICAL DEMANDS: * Frequently required to stand * Frequently required to walk.  * Frequently required to sit.  * Frequently required to talk or hear.  * Occasionally required to lift light weights (less than 25 pounds)  * Specific vision abilities required for this job include: close vision, color vision and ability to adjust or focus * Ability to travel, including overnight stays by plane, train or auto, up to 50%   WORK ENVIRONMENT:  * The noise level in the work environment usually is quiet. Equal opportunity employer, and does not discriminate on the basis of race, color, religion, sex, pregnancy, national origin, disability, age, genetic information, veteran status, sexual orientation, gender identity or any other characteristic protected by federal, state or local law.