Regulatory Submission Publisher Jobs in Englewood

... are described here: The Specialist/Manager Regulatory Operations contributes to the strategic ... strategic planning and preparation of regulatory submissions and supports the formatting, ... organization, and structuring of major..

Conflicts Specialist Duties: Fostering a culture of integrity, and supporting an environment where individuals ask questions and report real or potential compliance-related concerns. Other functions include compliance education, as well as ..

Conflicts Specialist The candidate will under the direction of the Conflicts of Interest Manager performs functions related to firm's programs, processes, and policies with a particular focus on conflicts of interest ..

... REMS Operations, Medical Communications/Medical Affairs, Regulatory, or Safety/Pharmacovigilance. REMS and Risk ... and process management related to regulatory RMP (Risk Management Plan) and ... to the following: Risk Management..

Senior Manager - Marketing The candidate under direction of the Director of Practice Group Marketing, will work closely with practice leadership, the firm's lawyers and other marketing team members to support ..

Regulatory Compliance Specialist IV The candidate ... existing audit compliance efforts and regulatory compliance obligations, and to support ... in alignment with industry and regulatory requirements and expectations. Creates and..

... Matter Expert for input to regulatory product labeling and participate/provide input ... provide safety lead support global submission document production and review. Lead ... Topic Reviews) and ad hoc..

... tracking tool Leads ad hoc regulatory safety requests by obtaining data ... surveillance activities, signal assessment, and regulatory safety requests for multiple compounds ... development and authorship Leads ad-hoc..

... Matter Expert for input to regulatory product labeling and participate/provide input ... in development and support global submission document production and review. Provide ... Topic Reviews) and ad hoc..

... be responsible for development and submission activities (to Health Authorities) in ... work with Celgene teams (Safety, Submission, etc.) and the overarching Global ... to support the overall RMP/REMS..

... for clarification or revision Assures regulatory guidelines are followed for electronic ... electronic format and review both submission ready documents and dossiers for ... Demonstrates a working knowledge of..

... information May lead ad hoc regulatory safety requests by obtaining data ... surveillance activities, signal assessment, and regulatory safety requests for multiple compounds ... strategy and authoring of integrated..