The Director of Global Material Review Medical Compliance Excellence is accountable for processes, standards and compliance monitoring supporting the scientific development and review of medical content of pharmaceutical promotional and non-promotional materials for marketed and investigational products, ensuring that presentations of medical and scientific information meet various standards for pharmaceutical promotion and scientific exchange.
This role is accountable for implementing and maintaining business processes, regulatory compliance, electronic review system strategies, and productivity initiatives. In addition, 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, corporate marketing, OEC, and all functional areas of Global and US Medical Affairs.
- Establishes and 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 globally.
- Develops and maintains processes and standards outlining requirements for the creation, review, and approval of non-promotional medical materials for use with external customers. Optimizes and aligns processes to support departments across Medical Affairs, considering other business areas impacted by material review.
- Contributes to the development and implementation of processes and tools to support compliant medical review of promotional material creation and review while ensuring the organization’s ability to effectively deliver against strategic and financial plans.
- Provides expert guidance on internal GMA guidance, AbbVie policies and external regulations 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, knowledge of industry trends and processes. Provides recommendations to senior or executive level management to define and implement improvement strategies and priorities in order to support global and US Medical Affairs organization.
- Oversees the development and reporting of metrics and related compliance monitoring for area of accountability. Identifies need for process improvements related to promotional and non-promotional review, develop improvement plans and drives implementation of planned improvements.
- Accountable for consistent and accurate updates on medical promotional and non-promotional material creation, review and compliance performance KPIs to mitigate business compliance risks.
- Ensures Medical Affair employees complete required training to do their jobs through development, maintenance, and reporting of role-based training plans.
- Responsible for evaluating and implementing technology solutions to enhance or facilitate operations within Medical Affairs related to material review of promotional and non-promotional materials.
- Anticipates environmental changes, fosters communications across TAs globally and collaborates with Global leadership to implement risk management strategies related to material review.
- Supports commercial and scientific processes to ensure product and pipeline success. Negotiates with Commercial, Regulatory, Legal, and Compliance counterparts to foster efficiencies that have company impact. Serves as key resource to organizational counterparts and senior/executive management.
- 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 required (PhD, RN, PharmD, RD)
- Previous Medical Affairs medical review experience required. 10 years experience in pharmaceutical industry; 5 years should be in Pharmaceutical Promotion. 1-2 years Global material review experience is preferred.
- 3 years leadership in Pharmaceutical Promotion; demonstrated ability to manage cross-functional teams of exempt and non-exempt staff and ability to make well-balanced risk decisions
- Clear ability to influence others without direct authority.
- Significant supervisory/leadership experience managing people or multiple projects. Experience in leading in a multi-task environment as well as in a virtual and matrix organization. Excellent leadership, self-management and organizational skills; able to manage workload, set personal and team priorities and adjust as needed.
- Demonstrated ability to set and execute on strategies with global and cross-functional and departmental impact. Strong business acumen: ability to think strategically and translate a strategy to an innovative and implementable plan.
- Must have proven experience in situations of conflict resolution, problem solving and crisis management. Excellent interpersonal, communication, 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)
Job Type: Experienced