Director Field Medical Standards and Processes
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.
The Director Field Medical Standards and Processes is accountable for processes, standards and compliance monitoring supporting Field Medical activities. This role is accountable for development of standards that ensure compliant Field Medical business processes and activities and the electronic system strategies required to document these activities. This role is responsible to build positive and collaborative relationships in matrixed and cross-functional team environments incorporating diverse groups from Global, Area and Affiliates and US therapeutic area teams, Regulatory Affairs, Legal, Public Affairs, Training, Marketing, OEC, and all functional areas of Global and US Medical Affairs.
Develops and implements processes and tools to support Field Medical compliance while ensuring the organizations ability to effectively deliver against strategic and financial plans. Establishes and fosters the vision and strategic direction for Field Medical within the organization, ensuring clear processes, policies and procedures support professionals dedicated to supporting accurate, high quality and compliant scientific communications for AbbVie both globally, and in the US.
Develops and maintains processes and standards outlining requirements for Field Medical activities. Optimizes and aligns processes to support departments across Medical Affairs, considering other business areas impacted.
Provides expert guidance on regulations and their impact on Field Medical practices, standards and procedures. Expertise stretches beyond scientific communications 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 to support global and US Medical Affairs organization.
Oversees the development and reporting of compliance metrics and related compliance monitoring for area of accountability. Identifies need for process improvements related to Field Medical activities, develops improvement plans and drives implementation of planned improvements in collaboration with the business.
Accountable for consistent and accurate updates on Field Medical policies and procedures, and compliance performance KPIs to mitigate business performance risks.
Ensures Medical Affair employees complete required compliance training to do their jobs through development, maintenance, and reporting of role-based training plans.
Remains current in GMA related regulations, AbbVie policies, and new regulations affecting GMA to ensure systems, processes, and procedures accurately reflect current global standards.
Responsible for evaluating and implementing technology solutions to enhance or facilitate operations within Medical Affairs related to Field Medical activities and scientific communications.
Collaborates with the business to ensure Audit preparedness across Field Medical.
Anticipates environmental changes, fosters communications across TAs throughout US and Global HQ and collaborates with TA Heads and Leads to implement risk management strategies related to Field Medical activities.
Supports scientific communications and Field Medical policies and procedures 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 Field Medical or related role.
3 years leadership in Pharmaceutical Industry; 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; 6 years of field organization or operations experience as a leader in a Medical Affairs preferred. Excellent leadership, self-management, and organizational skills; able to manage workload, set personal and team priorities and adjust as needed; financial acumen competence.
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. Able to 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.