- Merck & Co. (Rahway, NJ)
- …Primary responsibilities include, but are not limited to: Serve as the Regulatory Project Lead for assigned device and combination products, guiding ... cross-functional teams to ensure regulatory compliance throughout development and commercialization. Mentor team members while driving project timelines and… more
- Merck & Co. (Rahway, NJ)
- …and Clinical Safety , including training process standards and strategies to ensure optimal quality and compliance in Global Regulatory Affairs and Clinical ... regulatory policies that support work that is executed in Global Regulatory Affairs and Clinical Safety .Ensure organizational compliance with global… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Label Management systems (LIFT, SPL, ALiCE, novoGlow, etc.) Works directly with Regulatory Project Mangers to prepare labeling items consistent with content ... regulatory labeling-related activities. Updates internal processes to ensure compliance with health authority requirements and expectation Physical Requirements… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes ... serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational...may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late… more
- Merck & Co. (Lower Gwynedd, PA)
- …improvement.Direct support of validation activities and all other associated Quality functionsUnderstands and applies regulatory / compliance requirements ... and enable late-stage clinical trials through the generation of timely, high- quality regulated bioanalytical data. A combination of molecular (eg, PCR), serology… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulatory standards, contributing to the organization's success and regulatory compliance .ResponsibilitiesCoordinate global regulatory dossier generation ... is to lead and/or support complex filing activities, ensuring compliance with technical and regulatory standards. This...with project management expertise. Create and maintain regulatory project and submission plans, schedules, and… more
- Merck & Co. (Rahway, NJ)
- …lead Global Clinical Supply Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate ... the operational/executional arms within the business. The Program Clinical Supplies Project Manager serves as the primary program-level Global Clinical Supply point… more
- Merck & Co. (Rahway, NJ)
- …clinical supplies . Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical ... within the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic and operational plans for all… more
- Merck & Co. (Durham, NC)
- … Control will be responsible for activities that support cGMP and regulatory compliance during method qualification/validation and routine product testing to ... concepts and techniques as they relate to laboratory testing start-up, regulatory requirements for new assay development/validation, project timelines and… more
- Merck & Co. (Durham, NC)
- …safety)Collaborate with site compliance team to ensure adherence to regulatory requirementsReview and approve Quality NotificationsTrain employees on new or ... packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our internal… more
- Merck & Co. (Durham, NC)
- Job DescriptionSenior Specialist Quality AssuranceSenior Specialist, Quality Systems and Compliance (P3)Our company is expanding its global recombinant ... for daily support and oversight of all production processes to ensure compliance with regulatory requirements as well as policies and procedures.-Responsible… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … team members to ensure that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead(s) (GQLs) and Regional Quality ... and Specialty Medicine strategic priorities, by reviewing and monitoring the status of Quality Events (QEs), CAPAs and GCP compliance matters raised to the… 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 ... Qualifications Bachelor's degree or equivalent experience required 8+ years of operations, quality assurance, call center, compliance , project management,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes ... tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes… more
- Merck & Co. (Rahway, NJ)
- …large multifaceted projects as the leader of a cross-functional team.-Ensures project results meet requirements regarding technical quality , reliability, ... phases whenever possible.Provides timely and accurate information and status updates to project sponsors and management.Champion compliance and safety; promote a… more
- Merck & Co. (North Wales, PA)
- …and systems for a pharmaceutical company, ensuring compliance with regulatory requirements and maintaining high- quality standards.- Product managers must ... strategies that meet regulatory requirements and ensure patient safety, quality and compliance .-Oversee PV processes: Responsible for overseeing all PV… more
- Aequor (Thousand Oaks, CA)
- …QUALIFICATIONS? 5 years of biopharmaceutical experience responsibility in a quality , analytical development, process development, pharmaceutics, regulatory , or ... available - admin hours 8-5 Mon - Friday. Ideal candidate: Experience with quality management systems and 5&plus YOE. Nice to have: Veeva knowledge. Ex candidates… more
- Merck & Co. (Rahway, NJ)
- …development.Knowledgeable of the Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across ... multidisciplinary team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes ... rare diseases and immune disorders. Summary This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as… more
- Merck & Co. (Rahway, NJ)
- …GMP Operations, will oversee laboratory compliance across multiple sites, managing regulatory audits, internal quality and safety audits, quality ... GMP Operations team.Ensure inspection readiness and offer prompt support during regulatory , quality , and safety inspections.Address audit findings and identify… more
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