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Duties: Supporting commercial business units with the review and assessment of advertising and promotional issues through participation in the MLR review committee. Assessing disease state and medical materials through the MLR review committee. Providing healthcare compliance guidance for various therapeutic areas including Dermatology, Biologics, Neuroscience, Oncology and Ophthalmology. Advising company executives on healthcare compliance policies pro... read more
Director, Regulatory Affairs Strategy
Responsibilities: Regulatory Knowledge: Maintains a high level of regulatory knowledge and provides regulatory advice. Agency Interactions: Acts as single point of contact to FDA for products/projects. Liaises, negotiates and leads FDA and/or EMA interactions, including appropriate documentation of the interaction, decisions and outcomes with oversight from supervisor. 3. Dossier Submissions: Independently leads the preparation, coordi...
Senior Counsel - Legal & Compliance
The candidate will be primarily responsible for providing legal advice, guidance and support related to (1) transactions in all areas, including Corporate, Commercial (GPO, Wholesaler Distribution Agreements, etc.), Research and Development, and Manufacturing and Supply Chain; (2) Compliance; and (3) review of promotional materials. Reporting to the General Counsel, will be responsible for collaborating across all levels of the organizat...
Director/Senior Director, Regulatory Science & Policy Lead for Consumer Healthcare GBU
Duties: Develop effective and systematic approaches to bring functional excellence to Regulatory Intelligence and Policy across Global Business Unit with emphasis on key markets. Drive best practices and excellence in execution within the department and cross-functionally. Contribute to the creation, standardization and implementation of systems/processes to monitor the regulatory enviro...