- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Good Documentation Practices (GDocP)Supervise Finishing activities to ensure operational efficiency, regulatory compliance , safety and production goals are ... are trained and work in compliance with applicable SOPs, cGMPs, regulatory requirements, safety , environmental and company policiesPerform other duties as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …related payment schedules) Advanced knowledge of Regulatory and Compliance requirements related to Pharmaceutical Pharmacovigilance/ Safety reporting Advanced ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...including, but not limited to, Master Service Agreements (MSAs), Safety Data Exchange Agreements (SDEAs) and Statement of Works… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …existing CMR employee on-boarding, cultural engagement, technical/role-specific training and GxP/ Regulatory compliance across CMR functions. Position will serve ... execution, maintenance of technical training across all CMR functions, and compliance across clinical development, medical, and regulatory roles/processes/SOPs… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking a QA Laboratory Compliance Manager as part of the Quality team based in Raritan, NJ. Role ... OverviewThe QA Laboratory Compliance Manager role is an exempt level position with responsibilities for providing quality oversight over the compliance program… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Patient Safety , Quality, NNI IT and Telephony, Medical Information, Compliance , Regulatory , Legal and Privacy. External relationships include Patient Support ... Essential Functions Partners with PSS Program Management team to ensure vendor compliance with all quality/ safety requirements; educates on process requirements… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Raritan, NJ. Role OverviewThe Quality Compliance Manager is responsible for regulatory compliance supporting the production of autologous CAR-T products for ... and independent audits; manage audit responses and observation resolution.Drive site compliance to regulatory , enterprise, and global requirements through… more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... and regulatory postureDemonstrated working knowledge of FDA, ICH, and other regulatory requirements for CMC.- Strong experience in safety and environmental… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …plant processesDevelop and maintain electrical and control schematics while ensuring compliance with safety and regulatory standardsProvide technical ... ISO, EU and ICH. Understand 21 CFR Part 11, cGAMP, and other regulatory guidance associated with computer / automation based systemsAbility to read electrical… more
- Merck & Co. (Rahway, NJ)
- …and accurate information and status updates to project sponsors and management.Champion compliance and safety ; promote a culture of diversity, inclusion, and ... manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction… more
- Merck & Co. (Durham, NC)
- …work environment with optimized product quality and manufacturing processes and regulatory compliance . GENERAL PROFILE Provides leadership and direction through ... all production equipment.Daily support of all production equipment to ensure area safety , compliance , production and financial goals are metSpare parts… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …plant processesDevelop and maintain electrical and control schematics while ensuring compliance with safety and regulatory standardsProvide technical ... support for system commissioning, start-ups, and ongoing maintenance both locally at multiple facilitiesPeriodically review technology advancements to provide a competitive advantage through continued education, seminars, and trade shows to provide a… more
- Merck & Co. (Durham, NC)
- …tours to provide area/process overview information to visitors/auditors upon request. Quality & Safety Compliance Foster strong safety culture on the team ... safety issues and completing corrective/preventative actionsDrive culture of compliance through actions, consistent quality-driven decision making, and coaching… more
- Merck & Co. (Millsboro, DE)
- …and unregulated species including chickens, turkeys, dogs, cats, rabbits, and rodents.Assure compliance with all federal and state regulatory requirements for ... compliance with governmental regulations, and corporate/site policies including safety and biosafety.Utilize our systems such as Reliance, Atlas SRM, WorkDay,… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …(patient safety , rights and wellbeing; data reliability; scientific integrity; regulatory and process compliance ) for monitoring and site management ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...and Closure) for assigned sites and clinical trials Verifies safety reporting and the proper handling, monitoring and storage… more
- Merck & Co. (Rahway, NJ)
- … monitoring, analysis of data and communication of study findings. (b) Global Regulatory Affairs and Clinical Safety : Focus on late-stage and lifecycle drug ... working with clinical and cross-functional teams as clinical programs progress toward regulatory approvals. - Successful candidates will spend their first year in… more
- Merck & Co. (Rahway, NJ)
- …characterization such that the process is scalable without compromising stability, safety , efficacy, and delivery. During development, we leverage smart experimental ... packaging, compatibility characterization for processing and administration, and supporting regulatory filings. Have deep fundamental knowledge around large molecule… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …include brand marketing, market access, Enterprise Insights, sales, medical/CMR, legal, compliance , and regulatory . Other internal relationships include Public ... contractual arrangements, SOPs, KPIs, and budget. Ensure adherence to all compliance and regulatory @requirements Fiscal Management Demonstrate fiscal discipline… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …include brand marketing, market access, Enterprise Insights, sales, medical/CMR, legal, compliance , and regulatory . Other internal relationships include Public ... contractual arrangements, SOPs, KPIs, and budget. Ensure adherence to all compliance and regulatory requirements Fiscal management: Demonstrate fiscal discipline… more
- Merck & Co. (Durham, NC)
- …for daily support and oversight of all production processes to ensure compliance with regulatory requirements as well as policies and procedures.Responsible ... for establishing processes that ensure required safety guidelines are followed.Review and approve qualification/validation documents for equipment and process (ie,… more
