Job Description

Description

• Accountable for 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 for building positive and collaborative relationships in matrixed and cross-functional team environments incorporating diverse groups from Global Affiliates, therapeutic area teams, Regulatory Affairs, OEC, and all functional areas of Global Medical Affairs.
• Implements policies to support accurate, high quality and compliant medical and commercial communications for Globally 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.
• 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.
• Manage the review of both promotional and non-promotional materials.
• Address compliance inquiries for both US and global regulations.

• Health related background: BSN/PharmD, (at a minimum Pharma Experience, 1-5 years experience would be ideal)
• Advanced degree or extensive experience in operations and/or performance (commercial/customer) excellence is preferred (PhD, RN, PharmD, RD).
• 2-5 years of experience
• Experience in medical review experience preferred
• 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.
• Experience with the application of FDA OPDP regulations, guidance regarding Advertising and Promotion (a plus would be for international regulations experience)
• Ability to review and monitor Medical Materials: scientific information to meet standards for pharmaceutical promotion/scientific exchange.
• Can help to develop/provide input on supplemental training for medical reviewers for US/OUS audiences
• Ability to work on updating SOPs across the business
• Proficient in MS Office tools and Veeva for material review, along with knowledge of global regulatory protocols.
• Have a solid understanding of non-promotional updates.

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