- Insmed Incorporated (NJ)
- …other, and for the future of science, we're in. Are you?About the Role:The Associate Director, Regulatory Affairs, CMC will be responsible for reviewing the CMC ... post approval changes, providing regulatory impact assessments, and coordinating with regional RA-CMC leaders to formulate regulatory strategies for… more
- Insmed Incorporated (NJ)
- …the future of science, we're in. Are you?About the Role:The Associate Director, Programming provides technical leadership and ensures adequate programming support ... Collaborates with cross-functional team members within Biometrics, Clinical Operations, Regulatory , and Clinical Development, as well as with external vendors.… more
- Merck & Co. (Rahway, NJ)
- …Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on document production ... industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems...industry experience at least 6 of those in a regulatory and/or compliance area and experience with technical systems… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director- Device Tech Transfer is a leadership role within the Device Development and Technology Organization. Thisposition is ... a focus on autoinjectors, prefilled syringes, and other drug deliverysystems. The Associate Director will collaborate with a team of engineers and technical staff… more
- Merck & Co. (Rahway, NJ)
- …DescriptionJOB DESCRIPTION SUMMARY Primary activities include but are not limited to: The Associate Principal Scientist is a DVM and/or PhD whose primary function is ... and report clinical laboratory and field studies that will support the regulatory approval of new companion animal and livestock products. The position requires… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Summary: -The Associate Director of Device Technology is a key leadership role within the Device Development and Technology Organization. This ... a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The associate director will be a technical subject matter expert on the device… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Durham, NC)
- Job DescriptionQuality Assurance Associate SpecialistOur Quality Assurance group ensures every single material inside our products is manufactured, processed, ... our incredibly high standards of quality and meets all regulatory requirements. Partnering across our-internal manufacturing facilities, external contract… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Associate Director, Patient Services Quality & Process leads quality assurance and process ... training, and data-driven optimization aligned with Insmed's strategic goals.The Associate Director, Patient Services Quality & Process is responsible for… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe USDA Compliance Subject Matter Expert (SME) - Associate Director, will report to the Animal Health Global Quality Compliance and Technical Lead.-- ... GxP compliance concerns.Maintain up-to-date knowledge base with respect to emerging regulatory trends and changes in regulations and standards to incorporate into… more
- Insmed Incorporated (San Diego, CA)
- …we're in. Are you?About the Role:Insmed is seeking a Senior Research Associate - Lab Technician with specialized expertise in supporting preclinical and ... and interpret experimental data, contributing to reports, presentations, and regulatory documentation.Maintain accurate electronic laboratory notebooks and ensure adherence… more
- Cipla (Hauppauge, NY)
- …working outside of Cipla's US Subsidiaries or Affiliates. Job Title: QA Associate (Reviewer) Location: 7 Oser Avenue Hauppauge, NY (Onsite) Employment Type: ... benefits. Shift: Second Shift - 3:00pm - 11:30pm Job Overview: The QA Associate (Reviewer) is responsible for review of batch production records, ensuring that all… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees the management of PV ... Regulatory Intelligence (PVRI) and dissemination across CSPV stakeholders for...CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs. Facilitate operational meetings with CROs, License Partners,… more
- Merck & Co. (Rahway, NJ)
- …and campus planning?- Have you advised on design standards, project scope, and regulatory compliance as well as act as a liaison with internal department ... building design standards, open space and site planning guidelines, and regulatory compliance such as ADA, environmental, and building codes.Ensure quality control… more
- Merck & Co. (Lower Gwynedd, PA)
- …trusted insights.- The PDMB Regulated Bioanalytics Department is seeking a Data Management Associate to join our LIMS & Data Management group. This role will support ... utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the Advance facility will not be fully constructed and… more
- Merck & Co. (Rahway, NJ)
- …areas and routes of administration, including inhalation, implantation, and injection.The Associate Principal Scientist will lead the definition and execution of ... Company and with external partners.Author and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …we work together to change lives for the better. The Position The Associate Director, Consumer Social Media Strategy is a high-impact, hands-on leadership role ... deep expertise in consumer social media strategy, planning and execution. This Associate Director Consumer Social Media Strategy is accountable for creating and… more
- Novo Nordisk Inc. (Boulder, CO)
- …of both worlds to develop new medicines for patients. The Position The Associate Director of Drug Product Manufacturing is accountable for all clinical drug product ... such as Quality Assurance/ Control, Chemical Development, Program Management, Regulatory , Analytical Development, Materials Management, and Clinical Supply Write,… more
- Merck & Co. (Rahway, NJ)
- …(as a lead GCS Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines, strategies and ... Development, Logistics, Multiple Therapeutic Areas, Process Optimization, Publications Management, Regulatory Compliance, Risk Management, Sourcing and Procurement, Strategic Planning,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …we work together to change lives for the better. The Position The Associate Director, Media Relations & Issues Management is accountable for establishing and leading ... and Public Affairs, Legal, Finance and Investor Relations, Clinical, Medical and Regulatory , plus other cross functional teams as needed. Key relationships in NN/AS… more
