- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is ... strategy and quality plan closely aligned with the Global Oncology Medical Affairs (GOMA), Oncology Business Unit (OBU) and Specialty Business Unit (SBU) Medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA ... technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of a CDx study/IVDR performance evaluation study integration of an assay into clinical testing (before testing) and once data is ready for CDx submission (after ... to external diagnostic business partners specifically:Use of CTA/CDx within clinical trialsDevice protocols and SAPsDevice non-significant/significant risk determinations (both… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to regulatory agencies. Supervise designated personnel. Relationships Report to the Director Regulatory Affairs . Develop and maintain positive rapport and ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...Position Manage and oversee all assigned projects/products/processes. Assist the Director in assuring Novo Nordisk compliance with internal SOPs… more
- Merck & Co. (Boston, MA)
- …in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; and assist the Executive Director and/or ... medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will... development (pre- clinical to post-licensure). The Senior Director will manage the entire cycle of late-stage … more
- Merck & Co. (Boston, MA)
- …and will interact externally with key opinion leaders.-Specifically, the Executive Director may be responsible for:Evaluating pre- clinical and translational work ... opportunities.Managing other Directors and/or Senior Directors responsible for Atherosclerosis clinical development projectsThe Executive Director may supervise… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo. The candidate will collaborate globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC, and Clinical ... to author the Dose Preparation Instructions and address questions from the clinical sites. The candidate will optimize and continuously improve the Pharmacy Manual… more
- Merck & Co. (New York, NY)
- Job DescriptionOur Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry professionals ensuring ... are seeking a Growth and Improvement minded Oncology Regional Medical Scientific Director that can help drive our Strategic Operating Priorities. Invent-- Pursue the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director / Principal Scientist, Regulatory Affairs Liaison , is responsible for the development and implementation of worldwide regulatory ... Teams and the regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Key… more
- Eisai, Inc (Raleigh, NC)
- …If this is your profile, we want to hear from you. The Director Western Supply Chain Management (SCM) Unit is accountable and/or responsible for providing ... production plans and/or transition plans to meet the demand forecast. The Director , Western SCM Unit will lead a cross-functional team driving excellence in… more
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