- Jazz Pharmaceuticals (Redwood City, CA)
- …meeting and information, and ensuring timely responses. Collaborate with the GRADS Compliance Regulatory and Labeling Partner to ensure continuous improvement ... that the appropriate management reviews are established. In partnership with GRADS Compliance Regulatory and Labeling Partner, attend and participate in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Maintain learning management systems and track training completion rates to ensure compliance with safety and regulatory requirements Lead the development and ... for purpose learning Evaluate training curricula and make adjustments based on feedback, compliance audits, and evolving regulatory standards Key Area #2 Lead… more
- Jazz Pharmaceuticals (Philadelphia, PA)
- …opportunities for the GRA-CMC team and the broader GRA team. Ensure continued regulatory compliance of products though adherance to c hange control and Regul ... www.jazzpharmaceuticals.com for more information. Brief Description: The Associate Director position, Regulatory Affairs Global CMC is responsible for… more
- Eisai, Inc (Nutley, NJ)
- …make a difference. If this is your profile, we want to hear from you. The Associate Director, Compliance Operations will be a key member of Eisai's US Ethics & ... including vendor selection and onboarding Present updates to senior leadership on compliance trends, regulatory changes, and program enhancements C ontribute to… more
- Merck & Co. (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Utilize extensive experience in ... Job DescriptionJob Summary: -The Associate Director of Device Technology is a key...conducted with the highest regard for safety, quality, and regulatory compliance , aligning with the company's divisional… more
- Merck & Co. (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance .Essential Duties and Responsibilities:Program Leadership and Technical ... Job DescriptionThe Associate Director- Device Tech Transfer is a leadership...conducted with the highest regard for safety, quality, and regulatory compliance , aligning with the company's divisional… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …management processes across the global safety organization. The incumbent will ensure regulatory compliance , promote best practices, foster a culture of ... activities and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and… 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 ... authority (particularly USDA-APHIS-CVB-IC and/or -PEL) as an inspector, product reviewer, compliance officer, other GMP/ regulatory role or Site Quality Head… more
- Insmed Incorporated (NJ)
- …and timely execution of testing activities. Core responsibilities include maintaining regulatory compliance , ensuring data integrity, and driving operational ... for release, stability, and in-process control.Ensure external labs operate in full compliance with cGMP, regulatory expectations, and Insmed quality standards.… more
- Merck & Co. (Rahway, NJ)
- …Programs, FDA Regulations, IT Coordination, IT Operation, Pharmacovigilance, Policy Implementation, Regulatory Compliance , Regulatory Labeling, Regulatory ... 10 years of industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated environment OR a… 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 ... reporting for DSI products, both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety...PV Regulatory Intelligence (PVRI) and dissemination across CSPV stakeholders for… more
- Insmed Incorporated (San Diego, CA)
- …technical expertise and system documentation.Ensure data integrity, system reliability, and regulatory compliance across all phases of clinical development.Team ... future of science, we're in. Are you?About the Role:The Associate Director, EDC Programming will lead and oversee EDC...CFR Part 11, and CDISC ODM Standards.Data Quality & Compliance : Ensure EDC systems comply with regulatory … 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
- Merck & Co. (Rahway, NJ)
- …DescriptionReporting into the Director, Logistics and Distribution Technology the Associate Director, Logistics and Distribution Technology will be responsible and ... to shape the technical capabilities lead a global, cross-modality technical team.The Associate Director will lead a team of technical experts responsible providing… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …product profile (TPP) development, due diligence projects, and clinical- regulatory compliance . ResponsibilitiesEssential Duties and Responsibilities Clinical ... success etc.Provide expert recommendations based on scientific and medical analysis. Regulatory Compliance : Ensure adherence to FDA guidelines for 505(b)(2)… more
- Eisai, Inc (Baltimore, MD)
- …and system standards within the department to ensure reliability and compliance with company standards and governmental regulatory requirements. ... internal groups and coordinate calibration activities to support ongoing compliance , validation activities, operations activities, maintenances schedules, new equipment/instrument… more
- Novo Nordisk Inc. (Boulder, CO)
- …of technical teams required Experience working to standards required for regulatory compliance of Aseptic Processing facilities required Understanding of ... 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… more
- Eisai, Inc (Miami, FL)
- …career evaluation, coaching, mentoring, performance management and talent review. Ensure compliance with regulatory and other ethical guidelines relevant to ... your profile, we want to hear from you. The Associate Director/Director, MSLs is responsible for the leadership, direction...the pharmaceutical industry, and to ensure compliance with Eisai policies & procedures and standard operating… more
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