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... 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..
... 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..
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas ..
... 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..
... 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..
... 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..
... and ensuring compliance with global regulatory requirements. Position Summary / Objective ... relevant clinical trial documents and regulatory filings. Support evaluation & management ... products. Support Safety input for..
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and ..
... Vice President of Global Strategic Regulatory Operations (GRSO) reports directly to ... Senior Vice President of Global Regulatory Safety and Biometrics (GRSB) and ... accountable for delivering all global..
... role from early discovery to submission of marketing authorization applications. We ... Assisting in the preparation of regulatory documents including INDs, NDAs, and ... including INDs, NDAs, and BLA..
... 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..
... the development and implementation of regulatory documentation strategy to deliver key ... prioritization and execution of documentation submission strategy. Position Requirements PhD/MD/PharmD in ... of 10 years in pharmaceutical..
... the development and implementation of regulatory documentation strategy to deliver key ... prioritization and execution of documentation submission strategy Position Responsibilities Under the ... and manage the implementation of..
Associate Manager, Regulatory Publishing (BASKING RIDGE, NJ)Regeneron Pharmaceuticals, ... is seeking an Associate Manager, Regulatory Publishing (Basking Ridge, NJ) to ... documents. Manage the building of Regulatory submission deliverables such..
... 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..
... 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..
