- Takeda Pharmaceutical (Boston, MA)
- …co-ordination of logistics study planning and implementationConsistent with membership of the Clinical Review Board Committee, responsible for critical review ... Strategy (IDAS) and overall Integrated Global Development Plan (IGDP). Responsible for review of synopses, other relevant clinical study documents and Critical… more
- Merck & Co. (Rahway, NJ)
- …procurement function. - This position offers the flexibility of being either hybrid or remote , with teams based in US, Europe and Asia. - Key Role Responsibilities ... issue resolution Queue Management : Monitor and manage procurement queues, review purchase orders, change orders and marketplace purchases, assist suppliers with… more
- Merck & Co. (Rahway, NJ)
- …of preclinical discovery into compounds ready for assessment in large clinical populations.We are seeking a highly qualified physician-scientist with a proven ... 5-year experience in the pharmaceutical industry and Immunology R&D and clinical and academic expertise in Immunology-related areas such as Dermatology,… more
- Takeda Pharmaceutical (Boston, MA)
- …and executes a labeling implementation plan to incorporate new scientific, safety and clinical data, as well as Health Authority responses / feedback into CCDS, USPI ... of write-offs.Responsible for working with direct reports to develop and/or review the labeling implementation plan ensuring that the most up-to-date information… more
- Merck & Co. (Rahway, NJ)
- …management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/ III trials.- The knowledge must be ... principles and statistical methods applied to designing and analyzing clinical trials in support of worldwide regulatory submissions.This position involves… more
- Merck & Co. (North Wales, PA)
- …Serves as the medical representative within Product Development sub-teams (including Clinical , V&I, Commercial, Publications, and Label), leveraging the GMSA vision ... to headquarters submission (ex-USA) and in collaboration with RDMAs, while also serving as a review panel member on TA specific MISP's to support the EDSA review … more
- Merck & Co. (Rahway, NJ)
- …enables gain of critical internal experience during scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, training ... and/or support batch processing readiness and execution activities. Prepare, review , and/or approve GMP Documentation as appropriate. Author/Approve Standard… more
- Merck & Co. (North Wales, PA)
- …on training capabilities in the Business of Oncology in addition to support clinical and sales needs for Oncology customer facing positions. - The ORT interacts ... The focus of this role is to train on the Business of Oncology and clinical expertise aligned to in line promoted indications. Travel is required in this role (50%).… more
- Merck & Co. (Rahway, NJ)
- …and execute design verification strategies that successfully supports the clinical instruction(s) and commercial market approval(s) of combination products.Principal ... strategies for assigned drug-device combination product program(s) for successful clinical introduction(s) and commercial market(s) approval(s).Define design input(s)/ output(s)… more
- Merck & Co. (Rahway, NJ)
- …holders and others. To prepare outcomes research protocols, statistical analysis plans, clinical study reports and manuscripts intended for peer- review . To ... contribute to the value evidence strategy and associated studies which describe clinical , economic, and patient-centered unmet needs and the value the product… more
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