- Merck & Co. (Durham, NC)
- …cGMP-compliant state and represent the laboratory during audits and inspections ( regulatory , internal, safety )Build and maintain strong relationships with site ... meet established delivery timelinesProvide active support during audits and inspections ( regulatory , internal, safety )Collaborate with site compliance team to… more
- Merck & Co. (North Wales, PA)
- …cross-functional teams to develop and implement pharmacovigilance strategies that meet regulatory requirements and ensure patient safety , quality and ... with other departments: Collaborate with departments such as clinical, regulatory , and safety to ensure that PV processes are integrated into the… more
- Merck & Co. (Durham, NC)
- …and/or microbiological laboratory proceduresProvide active support during audits and inspections ( regulatory , internal, safety )Assist regulatory groups by ... and techniques as they relate to laboratory testing start-up, regulatory requirements for new assay development/validation, project timelines and budgeting.Build… more
- Merck & Co. (Durham, NC)
- …meet established delivery timelinesProvide active support during audits and inspections ( regulatory , internal, safety )Assist regulatory groups by providing ... and techniques as they relate to laboratory testing start-up, regulatory requirements for method transfer/validation project timelines and budgetingBuild knowledge… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …capture all communications via contact reports.Prepare, assemble and publish all regulatory documents (NDAs, INDs, Annual Reports, Safety Updates, Quarterly ... and partner with FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across all global projects,… more
- Merck & Co. (Rahway, NJ)
- …of GMP Operations, will oversee laboratory compliance across multiple sites, managing regulatory audits, internal quality and safety audits, quality notices, ... GMP Operations team.Ensure inspection readiness and offer prompt support during regulatory , quality, and safety inspections.Address audit findings and identify… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Good Documentation Practices (GDocP)Supervise Finishing activities to ensure operational efficiency, regulatory compliance, safety and production goals are met ... reports are trained and work in compliance with applicable SOPs, cGMPs, regulatory requirements, safety , environmental and company policiesPerform other duties… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with key high-level internal and external stakeholders and approves regulatory reports/submissions using expert safety knowledge.This position independently ... diseases and immune disorders. Job SummaryThe position develops the global safety strategy, oversees risk management activities, and recruits and develops staffing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …maintaining technical training programs related to GxP, Clinical, Medical and Regulatory affairs, Patient Safety required A thorough understanding and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...execution of CMR role-specific/technical training (eg clinical trial-related, patient safety , therapeutic area leads, MSLs etc.) across the US… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …members are trained and work in compliance with applicable SOPs, cGMPs, regulatory requirements, safety , environmental and company policiesPerform other duties ... of inspecting, packaging and/or labeling pharmaceutical products in compliance with all safety policies, cGMPs, and SOPs. The Group Lead, Finishing will rely on… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …compliance status and work in compliance with applicable SOPs, cGMPs, regulatory requirements, safety , environmental and company policiesPerform other duties ... in support of producing pharmaceutical products in compliance with all safety policies, cGMPs, and SOPs. This position supports the ongoing development,… more
- Merck & Co. (Durham, NC)
- … regulatory requirementsProvides active support during audits and inspections ( regulatory , internal, safety )Supports our Company's Manufacturing Division (MD) ... divisional and Quality initiativesEducation Minimum Requirement:B.S. degree in a science field required, preferably biology, microbiology, or biological sciencesRequired Experience and Skills:Good technical writing skills and high attention to detail1 year of… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …reports are trained and work in compliance with applicable SOPs, cGMPs, regulatory requirements, safety , environmental and company policies Perform other duties ... products in compliance with local procedures, corporate policies, and the regulatory requirements of the US Food and Drug Administration.Job Responsibilities Oversee… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …reports are trained and work in compliance with applicable SOPs, cGMPs, regulatory requirements, safety , environmental, and company policies.Perform other duties ... Manager II is responsible for being in compliance with all safety policies, cGMPs, and SOPs.Job Responsibilities:Manage large-scale, complex projects or multiple… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …compliance status and work in compliance with applicable SOPs, cGMPs, regulatory requirements, safety , environmental and company policies.Perform other duties ... Project Coordinator is responsible for being in compliance with all safety policies, cGMPs, and SOPs.Job ResponsibilitiesIndependently manage small projects and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …reports are trained and work in compliance with applicable SOPs, cGMPs, regulatory requirements, safety , environmental, and company policies.Perform other duties ... Project Manager I is responsible for being in compliance with all safety policies, cGMPs, and SOPs.Job Responsibilities:Manage the end-to-end delivery of small to… more
- Insmed Incorporated (San Diego, CA)
- …will provide clinical and scientific support to clinical development and operations, regulatory , medical affairs, drug safety , and quality assurance teams, as ... scientific review of information to support the development and updates for regulatory documents (ie, IND submissions, IND Annual Updates, DSUR, and Investigator… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company… more
- Merck & Co. (Lower Gwynedd, PA)
- …to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the AdVAnce facility will not be fully constructed and ready ... within the confines of departmental Standard Operating Procedures (SOP) and regulatory guidance; responsible for authorship of equipment-related SOPs and job… more
- Genmab (Plainsboro, NJ)
- …and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for leading ... portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr...labeling documents including Company Core Data Sheets (CCDS), Core Safety Information (CSI), United States Package Inserts (USPI), Summary… more
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Senior Manager Safety Regulatory