- Genmab (NJ)
- …data, and protocol deviations and is a key driver for inspection readiness , regulatory compliance, and successful data submissions.The Associate Director will lead ... workflows.Lead or contribute to initiatives that improve operational efficiency, inspection readiness , and regulatory compliance.Act as a Data Standards or Clinical… more
- Eisai, Inc (NJ)
- …difference. If this is your profile, we want to hear from you. The Sr. Manager is to lead collaboration efforts with RandD IT to implement and maintain Eisai's ... relating to clinical study Trial Master Files (TMF), ensuring regulatory inspection- readiness and compliance with applicable laws and regulations. The Eisai eTMF… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) ... individual in this role will also be responsible for overseeing inspection readiness and supporting internal audits and Health Authority (HA) inspections. For any… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking an Investigations Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Manager of CAR-T ... regulatory audits (including FDA, EMEA).Responsible to maintain permanent inspection readiness and actively support regulatory inspections. Hands-on in computerized… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulatory requirements, and other relevant guidelines.- Accountable for inspection readiness of laboratory data documentation filed/archived in Trial Master File ... and disease-specific requirements to DM standards teams and program teams.- Advise Manager , Laboratory Data Management on complex textbook range and unit requests as… more
- Merck & Co. (Durham, NC)
- …our Manufacturing Division (Associate Director).-This role serves as a Virtual Plant Manager - responsible for leading a cross-functional team in oversight of our ... Quality Agreements.- Launch Supply Risk Mitigation:-Ensure External Partner Site Readiness , Assist with Technology Transfer, Develop and Execute Manufacturing… more
- Aequor (Thousand Oaks, CA)
- …knowledge of full product manufacturing stages experience. The Supply Chain Project Manager (SCPM) will translate product variation strategy as determined by the ... Regulatory, Supply Chain, Manufacturing, Quality on status of GDCR and/or CFSCR readiness activities and related projects Represent the SCPM Hub in Project Planning… more
- Novo Nordisk Inc. (Durham, NC)
- …to drug development by redesigning and digitalizing the processes. Relationships Manager . Essential Functions Work closely with Product Owners from NT&XR and ... manner ensuring project timelines and deliverables required High flexibility and change readiness preferred Ability to manage intricate tasks with minimal or no… more
- Huntington Ingalls Industries (Fort Meade, MD)
- …make a difference. Cyber Electronic Warfare and Space team is currently seeking a Readiness Manager 2 in support of an exciting new effort supporting one ... Requirements Experience to include but not limited to: + Tracking and reporting readiness . + Leading working groups. + Understanding of existing readiness … more
- Spectrum Comm Inc (NV)
- Spectrum is seeking a Wing Readiness Manager (WRM) to provide support for our customer located at Creech AFB, Nevada. In this role you will be responsible for ... the readiness of unit personnel and equipment; this is critical...Responsibilities As our WRM, you be responsible for the readiness of unit personnel and equipment; this is critical… more
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