- Insmed Incorporated (NJ)
- …and evidence generation plans to demonstrate the value of Insmed's gene therapy product(s) for intended indication(s). The Senior Director proactively engages and ... a global role.What You'll Do: Lead development of HEOR strategy for gene therapy products from early clinical development through product launch and life cycle… more
- Insmed Incorporated (San Diego, CA)
- …resolution, etc.Develop risk mitigation plans for key partnersProvide regulatory review of documentation prepared by other technical functions supporting product ... and operational excellence.In partnership with Regulatory Operations, and/or third-party service providers, ensure high quality, on-time submission activities related… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …multi-site global manufacturing network responsible for manufacturing an approved cell therapy product in the Multiple Myeloma space including validation, data ... with internal and external partners to drive and establish cell therapy standards, policies, procedures across the validation lifecycleAlign global documentation… more
- Merck & Co. (North Wales, PA)
- …diseases, unmet medical need, patient reported outcomes (PRO) and the value of drug therapy as outlined in the OR planning process and generates data on a worldwide ... more junior members of the team.Present research plans and results to internal review and governance committees; to external experts and agencies (eg Public Health… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsibilities for supporting the document management process within a cell therapy manufacturing facility to support both clinical and commercial requirements in ... and document issuance and reconciliation.Key Responsibilities Serve as a Document Control reviewer for new and revised procedures and documents to ensure compliance… more
- Genmab (Berkeley Heights, NJ)
- …coordination of services among the patient's care team to ensure therapy can start and continue as per the healthcare providers ordersEnsure performance and ... to provide a positive experience. This position reports to the Patient Services Manager, Call Center Operations.The creation of our new internal Genmab Patient… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be responsible in handling day-to-day ... facility, equipment, systems and processes in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …industry, with at least 2 years in the Cell and Gene Therapy domain, including supplier landscapes for components and materials3-5 years' direct experience ... and other operational groups.Hands-on experience with cell and gene therapy components and associated manufacturing processes.Provide support in project management,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Compliance initiatives, such as inspection readiness, metrics implementation and review , overall regulatory compliance and implementation programs, and others as ... development and gathering of quality metrics for Legend's Quality Management Review (QMR).Support management of the Quality Management Review (QMR)… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process.Support manufacturing activities for cGMP compliance through ... provide guidance and determine immediate path forward for manufacturing quality issues. Review of all documentation, in accordance with Good Documentation Practices… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsible for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP ... resolution for manufacturing issues.Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints.… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …and oversee all nonclinical safety assessment activities for our cell and gene therapy programs. This individual will play a pivotal role in guiding toxicology ... execution for preclinical development programs in cell and gene therapy .Design, implement, and interpret nonclinical safety studies, including IND-enabling… more
- Insmed Incorporated (NJ)
- …Director for Interstitial Lung Diseases will develop, implement, and lead the therapy portfolio strategy and planning for Medical Affairs across all geographic ... that there is a strong medical voice.Build external relationship network across therapy area to support trial enrollment, launch prep, and to seek advice.Develop… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …includes medical treatments, customer solutions, and devices across multiple Therapy Areas including Rare Bleeding Disorders, Rare Endocrine Disorders, Rare ... across all digital touchpoints Content Development & Compliance: Coordinate the review and approval process to ensure all materials meet compliance standards.… more
- Insmed Incorporated (NJ)
- …identify and manage HCP resourcesBe a product champion and maintain knowledge of therapy areasEnsure a culture of compliance for the commercial teamLaunch Planning & ... patient community preferredFamiliarity/experience with regulatory and pharmaceutical legal promotional review processesA track record of developing and implementing marketing… more
- Insmed Incorporated (NJ)
- …is a strong medical voice represented.Build External relationship network across therapy area to support the indication, and gain advice.Develop data generation ... evolve product data generation plans and ensure there is OneMedical strategy. Review publications, help create medical backgrounders, FAQ and standard responses, and… more
- US Physical Therapy (Milford, DE)
- **Company Description** Premier Physical Therapy and Sports Performance was founded in 2007 to bring the region another level of care focused on the highest ... clinical standards. Premier PT is an outpatient orthopedic and sports physical therapy group treating musculoskeletal dysfunction and pain for all conditions. We… more
- Stony Brook University (Stony Brook, NY)
- …**Position Summary** The **Occupational Therapy Assistant** will provide occupational therapy services as assigned under the direction and clinical ... The OTA contributes to the evaluation and provides occupational therapy services as specified in the plan...or for a maximum of 90 days. An initial review of all applicants will occur two weeks from… more
- Memorial Sloan-Kettering Cancer Center (New York, NY)
- …Cancer Center (MSK) is seeking a **Pediatric Oncologist to join the Transplant and Cellular Therapy Service ** who is devoted to the care of children with cancer ... from birth through young adulthood (<27yr). The Pediatric 'Transplant and Cellular Therapy Service is a medium size transplant center (~50 Allo, 10-15 Auto,… more
- WesleyLife (Urbandale, IA)
- …and purpose. Come be a part of the revolution! ? **About the Role: Physical Therapy Assistant** As a **Physical Therapy Assistant** , you'll play a key role ... requires that you are currently licensed as a Physical Therapy Assistant in the state of Iowa._** **As a...that prioritizes respect, teamwork, and support **WesleyLife Hospice provides services in-home and elsewhere** ; wherever we're needed, we… more
