The Director of US Medical Review Standards is accountable for the medical accuracy and defense of US medical content of pharmaceutical promotions for products within one or more therapeutic areas, ensuring that presentations of medical and scientific information meet various standards for pharmaceutical promotion. This role is accountable for implementing business processes, regulatory compliance, electronic review system strategies, and productivity initiatives.
Watch: Career Advice
Key Responsibilities Include:
Establish the vision and strategic direction for an integrated team of professionals dedicated to supporting accurate, high quality and compliant medical and commercial communications for AbbVie, and translate department vision for strategic growth and development into team goals for US lines of business.
Lead a team of medical professionals with responsibltiy for Medical review within Medical Affairs including review of advertising and promotional materials
Provide strategy and direction for US Medical Affairs compliance-related policies/processes and quality oversight. Single point of contact and lead US Medical Affairs for initiatives related to compliance and quality.
Lead the development of processes and standards for the review and approval of medical affairs materials.
Optimize and align department resourcing to ensure Therapeutic and other business priorities and strategies are approproately covered.
Lead a cross-functional initiative to oversee and ensure all non-promotional materials, in addition to Medical Affairs materials, are approproately reviewed and documented prior to release from the organization.
Contribute to cross-functional strategic and tactical brand planning, and oversee analyses and development of medical position and messaging for highly visible pharmaceutical issues and product related developments
Negotiate with Commercial, Regulatory, Legal, and Compliance counterparts to make high-risk decisions that have company impact.
Oversee the development and reporting of metrics and related compliance monitoring for area of accountability. Identify need for process improvements in MR.
Provide Sr. Leadership consistent and accurate updates on medical review (SWARM) & compliance performance KPIs to mitigate business performance risks.
Ensure US Medical Affair employees are taking the training necessary to do their jobs through development, maintenance, and reporting of role-based training plans.
Remain current in GMA related regulations, AbbVie policies, and new regulations affecting GMA to ensure systems, processes, and procedures accurately reflect current global standards.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
Qualifications
Basic:
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; 3 years should be in Pharmaceutical Promotion.
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
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 or Commercial organization 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.
Send To A Friend
Posts
