- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Oncology and Specialty Medicine portfolios, in alignment with the business strategy. Lead the PV inspection management activities by ensuring readiness, compliance, ... alignment with regulatory and company strategy.Act as the management representative for all key health authority inspections (US FDA,...strategic non-project team and at CSPV strategic discussions.Take the lead as the Head of PV QA with Quality… more
- Insmed Incorporated (Bridgewater, NJ)
- …associated with delivering on Insmed's assets through completion of the drug development and launch processes. This position will be accountable for all necessary ... for initiating, planning, executing, controlling, reporting, and terminating the Integrated Development Plan and associated functional plans. As a leader, the Sr.… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …(IND, NDA, MAA, etc) and review sections from other functional areasServe as lead medical representative with regulatory agenciesIdentify and interact with key ... of marketed medicines and novel product candidates, from early- to late-stage development , in neuroscience and oncology. We actively explore new options for patients… more
- Catalent (St. Petersburg, FL)
- …the manufacturing floor when production events occur as defined by SOP and lead cross functional team to classify events and deviations of non-compliant issues ... Requirements: Proven ability to multi-task and demonstrate diplomatic skills.Ability to lead othersSkilled at leading groups (eg Kaizen events or other improvement… more
- Insmed Incorporated (Bridgewater, NJ)
- …for Quality related activities for commercial products including transition from development (Phase III) into commercial. Role is also responsible for critical ... is a supervisory position with 3-6 individual direct reports.ResponsibilitiesAdditional representative responsibilities will include, but not necessarily be limited… more
- Aequor (Thousand Oaks, CA)
- …order management and scrap containment, as well as reduce order-to-receipt lead -time. The team closely partners with the Site Procurement departments within ... supply Effectively engage key partners within supply chain, quality, finance, process development and other functional areas as needed Provide ad hoc reporting to… more
- Insmed Incorporated (Bridgewater, NJ)
- …or indication product line. This role leads the protocol statistical section development , study setup, execution, analysis, and reporting of clinical trials, and ... interacts with cross-functional teams.ResponsibilitiesAdditional representative responsibilities will include, but not necessarily be limited to, the following: … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …outcomes. This role will consist of these components including: Expand and lead our Data Stewardship Working Group (DSWG) across functional areas. This includes: ... updating, managing lineage, and adding context metadata in a structured fashion Lead and work with functional business data stewards on data quality initiatives… more
- Insmed Incorporated (Bridgewater, NJ)
- …Insmed's in-line rare disease respiratory product and will be responsible for the development and execution of strategies and tactics to ensure the brand's success. ... this position will develop plans and utilize appropriate tools and tactics to lead HCP personal and non-personal brand initiatives. As with all Insmed employees,… more
- Insmed Incorporated (Bridgewater, NJ)
- …demonstrating the value of Insmed's product(s) for intended indication(s), including development of HEOR evidence communication tools and support training of ... to support Insmed's business needs. This is a global role.ResponsibilitiesAdditional representative responsibilities will include, but not necessarily be limited to,… more
