Associate Director, Global Medical Material Review Compliance Excellence
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Reporting to the Executive Director, Global Medical Material Review Compliance Excellence, the Associate Director of Global Material Review Compliance Excellence is accountable for implementing processes, standards and compliance monitoring supporting the scientific development and review of medical content of Company promotional and non-promotional materials for marketed and investigational products. This role is responsible for ensuring that presentations of medical and scientific information meet standards for pharmaceutical promotion and scientific exchange. This role is responsible to build positive and collaborative relationships in matrixed and cross-functional team environments incorporating diverse groups from Global Affiliates and US commercial organizations, therapeutic area teams, Regulatory Affairs, Legal, Public Affairs, Sales Training, Marketing, OEC, and all functional areas of Global and US Medical Affairs.
- Develops and implements processes and tools to support compliant material development and review to support the ability of the organization to effectively deliver on strategic plans. Fosters the vision and strategic direction for material review within the organization, ensuring clear processes, policies and procedures support professionals dedicated to supporting accurate, high quality and compliant medical and commercial communications for AbbVie both Globally and in the US.
- Maintains and enhances processes and standards outlining requirements for the development, review, and approval of non-promotional materials for use with external customers.
- Provides expert guidance on regulations and internal policies and their impact on promotional and non-promotional material review processes and procedures. Expertise stretches beyond dissemination and/or promotion of medical and drug information into regulatory impact, Global business requirements, and knowledge of industry trends and processes.
- Responsible for the review and reporting of compliance performance KPIs and related compliance monitoring for material review to mitigate business performance risks.
- Ensures Medical Affair employees complete required training to do their jobs through development, maintenance, and reporting of role-based training plans.
- Bachelor’s degree with related health science background: BSN, BS, BS Pharm. Advanced degree or extensive experience in operations and/or performance (commercial/customer) excellence is preferred (PhD, RN, PharmD, RD)
- 8-10 years of industry related experience required. 5+ years experience in medical review experience 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.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Yes, 10 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity 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.