- Novo Nordisk Inc. (Plainsboro, NJ)
- …track, store, and disseminate critical CMR training documentation Ensures training and compliance to FDA Regulations, ICH Guidelines, and GCPs governing the ... work effectively cross-functionally are essential Knowledge and understanding of GxP training compliance , FDA Regulations, ICH Guidelines, and GCPs governing the… more
- Aequor (Chattanooga, TN)
- …safety requirements, Standard Operating Procedures (SOP's), Good Manufacturing Practices (GMP) Compliance , and Food and Drug Administration ( FDA ) regulatory ... Peer Relationships, Directing Others, and Comfort Around Higher Management o Experience in Food or Pharma manufacturing following FDA regulations is preferred. more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... budgeting guidance. Collaborating with cross-functional teams to ensure contractual compliance and driving continuous improvement. Works closely with suppliers to… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Operating Procedures, Work Instructions, Deviations, and other quality documents for cGMP compliance and consistency with FDA regulations. Aiding members of the ... various subunits of the Quality System and ensuring accountability. Achieving compliance with cGMP and other relevant regulatory requirements and fostering… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... maintaining product and establishment registrations (drug/establishment listings) and submission to FDA databases. This individual acts as the Subject Mater Expert… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance with all applicable Health Authority (HA) regulations and guidelines, ... may manage assigned staff, partnering with the Global Labeling Operations & Compliance group and across the cross-functional and cross- regional representatives on… more
- Merck & Co. (Rockville, MD)
- …health policy, or lawDoctorate degree and at least 5 years' experience with FDA or other health authority, either directly (working within a health authority) or ... ORMaster's degree and at least 8 years' experience with FDA or other health authority, either directory (working within...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance with all applicable Health Authority (HA) regulations and guidelines, ... may manage assigned staff, partnering with the Global Labeling Operations & Compliance group and across the cross-functional and cross- regional representatives on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global Pharmacovigilance (PV) service ... and aggregate reporting for DSI products, both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety and periodic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Independently leads cross functional teams through all labeling discussions with the FDA /CHMP while ensuring management alignment. Strategizes and plans for FDA ... by managing labeling development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to Core Data Sheets for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... are met according to timelines, budget, quality standards and in compliance . Proactively track, monitor and report trial risks, progress/performance, timelines, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.Key Responsibilities ... meet business objectives.Support Investigations team by providing quality and compliance input for continuous improvement; and remediation's.Lead continuous improvement… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as usual.Leads or assists in the tracking and investigation of quality and compliance issues OtherReview and update of DMA ProceduresMaintain compliance with ... to extract configurable data fields from a study protocolProficient in FDA regulations supporting the submission of adverse events for post-marketing and… more
- Lundbeck (Tucson, AZ)
- …patients including the full range of treatment options available. Pharmaceutical Environment/ Compliance - Ability to apply knowledge of pharmaceutical and regulatory ... environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. Ability to apply… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …ongoing development, manufacture, and distribution of pharmaceutical products in compliance with local procedures, corporate policies, and the regulatory ... methods for raw material, in-process, and finished product per USP and FDA guidanceProvides work assignments with communication of the expected timelines to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …complaints and other safety information related to Novo Nordisk products and in compliance with Novo Nordisk and FDA requirements Understands PSP operations, ... Patient Safety, Quality, NNI IT and Telephony, Medical Information, Compliance , Regulatory, Legal and Privacy. External relationships include Patient Support… more
- Merck & Co. (Rahway, NJ)
- …strategy.Knowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Aequor (Thousand Oaks, CA)
- …you will support the quality management system team to provide proactive compliance oversight to processes, functional areas and partner groups within the Corporate ... of Quality Management System Requirements, Product Standards / Regulatory Requirements (eg FDA CFRs for Biologics and Medical Devices, FDA Combination Product… more
- Merck & Co. (Durham, NC)
- …uses this knowledge in own workUnderstands and applies regulatory/ compliance requirements relative to their roleInfluence, motivate, and energize individuals ... will be responsible for activities that support cGMP and regulatory compliance during method qualification/validation and routine product testing to include the… more
- Merck & Co. (Durham, NC)
- …uses this knowledge in own workUnderstands and applies regulatory/ compliance requirements relative to their roleInfluence, motivate, and energize individuals ... be responsible for activities that support cGMP and regulatory compliance during facility design, construction, start-up method transfer/validation activities and… more
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