Senior Manager, MHI Compliance
About The Position
The Senior Manager, MHI Compliance reports to the Director, MHI Compliance and Independent Education, External Interactions. The role is accountable for compliance monitoring that supports effective implementation of standards governing external interactions and field medical activities. It implements written procedures and monitoring to support compliant field medical activities, contributes to training, conducts monitoring and auditing, and recommends and implements corrective and preventive actions. Primary areas of responsibility include field engagement and documentation standards. The position builds collaborative relationships across matrixed, cross-functional teams, including Global Headquarters, Affiliates, therapeutic area teams, Regulatory Affairs, Legal, the Office of Ethics and Compliance, and all functional areas of Medical Affairs + Health Impact (MHI).
Requirements
- Bachelor’s degree or ex-US equivalent, with a related health science background such as BSN, BS, or BS Pharm.
- 5–7 years of experience in the pharmaceutical, biotech, or medical device industry.
- More than 3 years of significant experience in Medical Affairs, Medical Excellence, Medical Operations, or a related pharmaceutical or biotechnology function, including leadership of cross-functional initiatives.
- Ability to influence others without direct authority.
- Excellent leadership, self-management, and organizational skills, including the ability to manage workload, set priorities, and adjust as needed.
- Excellent interpersonal, oral and written communication, and relationship-building skills.
- Ability to operate effectively in a matrixed environment, embrace change, lead new initiatives, make decisions without having the full picture, and handle risk and uncertainty.
Nice To Haves
- Advanced degree such as PhD, RN, PharmD, or RD, or extensive experience in Pharma/Biotech Compliance, Operations, and/or performance excellence.
- Field Medical experience.
- Experience developing and implementing monitoring oversight for business execution, including reporting and metrics.
- Previous experience in conflict resolution, problem solving, or crisis management.
Responsibilities
- Execute the compliance plan by monitoring activities related to external interactions and field engagement.
- Implement procedures supporting accurate, high-quality, compliant scientific communications globally.
- Pursue updates to regulatory guidance and internal policies and assess their impact on external interaction procedures.
- Implement procedures and actively monitor company CRM entries to support accurate, high-quality, compliant documentation.
- Review and report compliance performance KPIs and related monitoring for external interactions to mitigate business performance risks.
- Develop and support delivery of supplemental training resources and communications for relevant MHI team members on minimum standards for external interactions with healthcare professionals.
- Support completion of required MHI employee training by developing, maintaining, and reporting on role-based training plans.
- Conduct compliance monitoring and auditing, and recommend and implement corrective and preventive actions.
- Build positive, collaborative relationships across matrixed teams and functions.
Benefits
- Paid time off, including vacation, holidays, and sick time.
- Medical insurance.
- Dental insurance.
- Vision insurance.
- 401(k).
- Eligibility to participate in long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
