Sr. Manager, US Medical Affairs Monitoring and Compliance
Reporting to the Director, US Medical Excellence, the Senior Manager, US Medical Affairs (USMA) Monitoring and Compliance is accountable for supporting operational standards excellence within the USMA organization through internal monitoring. In accordance with the principles for maintaining a high-quality compliance program, this position will implement written procedures, ensure effective training, conduct monitoring/auditing and take corrective actions. Primary areas of focus will include field engagement and documentation, research operations and scientific content standards. This role will work closely with the Associate Director of Operational Standards Excellence and will be responsible for building positive and collaborative relationships in matrixed and cross-functional team environments incorporating diverse groups across US Medical Affairs (USMA), therapeutic area teams, Regulatory Affairs, Office of Ethics and Compliance (OEC), Legal, Global Medical Affairs (GMA) and other stakeholders.
- Execution of the compliance plan through monitoring of activity related to field engagement, scientific content adhering to scientific standards, research execution.
- Implements policies to support accurate, high quality and compliant medical communications for AbbVie in the United States through active monitoring of approved materials.
- Actively pursues updates to guidance on regulations and internal policies and their impact on promotional and non-promotional material review processes and procedures.
- Implements policies to support accurate, high quality and compliant documentation related to entries made into the company’s Customer Relationship Management (CRM) platform through active monitoring of approved materials.
- Responsible for oversight of the DocuSign process associated with the review and approval process (e.g., Medical Functional Planning).
- Responsible for Key Performance Indicator (KPI), Metric and Trend reporting to USMA leadership as well as the Compliance Review Committee (CRC) Forum.
- Responsible for the review and reporting of compliance performance KPIs and related compliance monitoring for material review to mitigate business performance risks.
- Supports the creation of Help Desk Knowledge articles for employees of US Medical Affairs. Serve as a business partner within Medical Operations and USMA through contributing to compliance-related educational content development.
- Collaborates with the Operational Standards team to ensure ongoing documentation and preparation for internal and external audit activities.
- Supports completion of required training by Medical Affairs employees through development, maintenance, and reporting of role-based training plans.
- Bachelor’s degree with related health science background: BSN, BS, BS Pharm. Advanced degree (PhD, RN, PharmD, RD) or extensive experience in Pharma/Biotech Compliance, Operations and/or performance excellence is a plus.
- 5-7 years of experience in Pharmaceutical, Biotech or Medical Device industry.
- Experience developing and implementing monitoring oversight for business execution, including reporting and metrics.
- Experience in medical review experience preferred, but not required.
- Ability to influence others without direct authority.
- Excellent leadership, self-management and organizational skills; able to manage workload, set personal and team priorities and adjust as needed
- Previous experience in situations of conflict resolution, problem solving, or crisis management preferred. Excellent interpersonal, communication (both oral and written), and relationship building skills.
- Able to operate effectively within a matrixed environment, embrace change, and lead implementation of new initiatives; can decide and act without having the total picture and can comfortably handle risk and uncertainty.
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity and affirmative action employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. If you would like to view a copy of the company’s affirmative action plan or policy statement, please email CorpJat_ABV@abbvie.com.