Job Description

Purpose:

Reporting to the Executive Director, Global Material Review, Medical Compliance Excellence, the Global Material Review, Medical Compliance Excellence is 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.

Top skills:

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

Responsibilities:

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.

Qualifications:

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).
Experience in medical review experience preferred, but not 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.

Recruiter

Phone

Sanjay Rawat

sanjay.rawat@collabera.com

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