- Amgen (Washington, DC)
- …new IVD regulations + Drive the development of and end-end process/playbook to conduct combined drug and device trials + Conduct gap assessments of current ... frameworks + Deep understanding of the R&D (preferred clinical operations), drug development and commercialization process + Proven leadership experience in building… more
- Takeda Pharmaceuticals (Boston, MA)
- …Company-wide patient safety expert for assigned oncology pharmaceutical / biological / drug -device combined products, accountable for the safety strategy and ... in support of safety update regulatory submissions, investigational and new drug applications and interactions with regulatory authorities worldwide. + Assists the… more
- Takeda Pharmaceuticals (Boston, MA)
- …the Company-wide patient safety expert for assigned pharmaceutical / biological / drug -device combined products, accountable for the safety strategy and major ... including risk minimization measures to address specific safety concerns related to the drug in development or a product on the market; evaluate and develop periodic… more
- Takeda Pharmaceuticals (Boston, MA)
- …the Company-wide patient safety expert for assigned pharmaceutical / biological / drug -device combined products, accountable for the safety strategy and major ... + At least 5 years of experience in pharmaceutical industry within Drug Safety/Pharmacovigilance, with both investigational and marketed products. + At least 3… more
- AbbVie (Philadelphia, PA)
- …safety surveillance *Responsible for safety surveillance for pharmaceutical / biological / drug -device combined products *Leading, setting the strategy and, ... when appropriate, authoring the key documents with safety data, including but not limited to, medical safety assessments, parts of submission dossier and regulatory responses. *Applying current regulatory guidance as appropriate for safety surveillance… more
- AbbVie (North Chicago, IL)
- …surveillance 2. Responsible for safety surveillance for pharmaceutical / biological / drug -device combined early oncology product and implementing risk ... management strategies for assigned product 3. Lead, set the strategy in collaboration with the development medical lead of study protocols and informed consents. When appropriate write the key pharmacovigilance documents, including but not limited to, medical… more
- Justice, Bureau of Prisons/Federal Prison System (Cumberland, MD)
- …individuals for successful reentry into our communities. Responsibilities Functions as a Drug Abuse Treatment Specialist (DATS) within a Bureau of Prisons (BOP) ... facility. Provides direct services, individual therapy and/or group counseling, drug education, residential and/or non-residential treatment services which focuses… more
- AbbVie (Irvine, CA)
- …of value generation. The Associate Director, Third Party Manufacturing Procurement, Drug Delivery Device, is responsible for leading strategic procurement for ... AbbVie's contracted drug delivery device category. Products include mechanical/electromechanical devices, combination products, auto injectors, injection molded… more
- Lotte Biologics USA LLC (Syracuse, NY)
- …Work is performed in a team environment within an Antibody Drug Conjugate (ADC) facility with classified areas requiring appropriate personal protective ... skids, filtration operations, isolator operations, aseptic technique, filling of final drug substance, etc.) + Maintains files, records data, logs activities, and… more
- Lilly (IN)
- …and confidential discussions. Importantly, an in-depth understanding of the VC ecosystem combined with deep understanding of the drug discovery and development ... Labs, best-in-class innovation hubs and ExploR&D with decades of enterprise learning and drug development expertise to serve as an investor and strategic partner to… more
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