at Axogen (View all jobs)
Tampa, Florida, United States
Job Summary of the Medical Affairs Operations Director
The Director of Medical Affairs Operations is responsible for the development and execution of Axogen’s Medical Affairs engagement strategy and the development and evolution of the supporting infrastructure to deliver the strategy. These capabilities may include, but are not limited to, digital systems to engage, track and monitor medical insights and information, medical/scientific conference activities, field medical activities for Medical Science Liaisons (MSLs), collaborations with internal and external stakeholders and ensure the delivery of credible, high value exchange of scientific, technical and medical information.. In our highly patient-centric environment the Director’s efforts will be essential in creating and streamlining processes for the organization. The Director will work directly with internal stake holders to implement cross functional engages, identify opportunities for efficiencies and improvements, and drive compliance with required processes, systems and policies.
Requirements of the Medical Affairs Operations Director
- Advanced degree, PharmD, PhD, MD/PhD in a scientific/medical discipline or equivalent combination of education and experience.
- A minimum of 10 plus years experience with progressively increasing responsibilities in the pharmaceutical/device industry in medical affairs, medical communications, medical information, scientific affairs or similar area; applicable job experience in medical affairs operations preferred.
- Demonstrated ability to collaborate with commercial and clinical functions.
- Evidence of ability to create and inspire high-performance teams.
- Very strong organization and critical thinking skills.
- Past success in managing simultaneous highly complex multiple projects.
- Excellent written and verbal communication skills.
- Ensure compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals and other business partners.
- Maintain strict adherence to company compliance policies and government regulations.
- Should have working knowledge with FDA regulations regarding marketing of medical device products and/or prescription drugs.
- Proficiency in PowerPoint, Excel, Word, Zoom/Teams.
- Willingness to relocate to one of the company HQ’s (preferably Tampa)
- Willingness to travel up to 40%
- Must be committed to full compliance with all company SOPs, regulatory requirements, and applicable laws.
Responsibilities of the Medical Affairs Operations Director
The specific duties of the Medical Affairs Operations Director include but are not limited to:
- Direct the annual strategic planning process to ensure medical projects are aligned with company priorities and resource allocation reflects the relative importance of therapeutic areas and products. Maintain alignment between medical and commercial functions in a way that achieves collective goals and respects/maintains compliance with corporate policies and regulations
- Supervise the Medical Affairs Operations Team; establish and guide annual performance management for medical affairs operations team
- Provide therapeutic knowledge or expertise to internal and external stakeholders
- Ensure the delivery of high value engagements and exchanges of scientific, technical and medical information with surgeons, clinicians, providers and other healthcare professionals.
- Establish project plans, with defined milestones, deliverables and key performance indicators to ensure on time and on scope delivery.
- Management and accountability to the Medical Affair Operations budget.
- Oversee contracting, purchase orders and other agreements related to Medical Affairs Operations are compliantly executed.
- Provide direct oversight and management of the field medical team in operationalizing the preparation of field medical insight reports, metrics, KPIs, training development, and literature reporting.
- Champion the role of Medical Affairs and the Operational team in cross-functional engagements across the business.
- Operationalize conference planning process and activities around external scientific presentations.
- Develop, implement, and maintain policies and procedures to facilitate and improve efficiency and ensure compliance across the Medical Affairs organization. Proactively monitor systems and processes to ensure compliance with company and industry standards. Identify and recommend solutions to problems and/or issues with personnel and/or processes across the department.
- Create, establish, monitor and evolve the existing Medical Affairs infrastructure to align with the prioritized business needs, industry benchmarks and compliance/regulatory guidelines.
- Develop Medical Affairs operational reports identifying operations team accomplishments, areas of focus, process improvements and issue resolution, to assist leadership team decision making.
- Support advancements in audit-ready, procedures and processes such as, medical legal review, and grant review.
- Curate metrics for routine reports to senior management.
- Develops and regularly reports on key performance indicators surrounding the medical resource use.
- Assist in the review of routine portfolio safety reports
- Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments
111 West Oak Ave., Tampa, FL 33602