- Axelon Services Corporation (New Brunswick, NJ)
- …as with business partners such as IT. This role will report to the Sr Director , Product Development Strategy. Responsibilities -Collect and curate data from ... Business Hours Product Development (PD) at Client is committed to accelerating CMC development to launch through strategic investments in Client development and… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. As a Senior Director of Quality Assurance CMC , you will be responsible for providing ... Engineering or related fields" + 15+ years of progressive GMP/ CMC Quality Assurance experience with 7+ years...ability to inspire and motivate direct reports at the director level and below. + Ability to work independently… more
- Integra LifeSciences (Plainsboro, NJ)
- …applicable regulatory agencies. **SUPERVISION RECEIVED** Receives minimal supervision from the Director , CMC Quality Operations. **SUPERVISION EXERCISED** ... what's possible and making headway to help improve outcomes. This ** Senior Manager, Quality Operations** will manage and provide oversight on Quality … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... to lead teams within overall CMC development project(s), to support Sr CMC Lead. In case no Sr CMC Lead is established, take main responsibility for … more
- Regeneron Pharmaceuticals (Armonk, NY)
- …managers, development program managers, medical monitors, as well as staff from quality , clinical compliance, regulatory, formulations, and IOPS ( CMC , external ... The ** Sr Manager, Clinical Drug Supply & Logistics** is...are performed on time, within budget and with good quality , in compliance with Regulatory Authorities' regulations / guidelines… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. **Summary** The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC ... for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data, authoring … more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …diseases, researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical, may be called upon to ... plans to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical also...claims. + Acts as liaison between Regulatory Affairs & CMC and other functional areas, including external contractors (eg,… more
- Novo Nordisk (Plainsboro, NJ)
- …this role, the incumbent will help develop multiple products. In doing so, the Senior Medical Director will work across different functional teams to support the ... merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both...a difference? The Position We are seeking an enthusiastic Senior Medical Doctor with a high degree of scientific… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Senior Director , Commercial Regulatory Affairs, is responsible for the development ... pertain primarily to marketed products in US and Canada. In addition, the Senior Director , Commercial Regulatory Affairs, in collaboration with Head, Regulatory… more
- Novo Nordisk (Plainsboro, NJ)
- …the drafting of medical/ scientific documents, safety monitoring, and data analyses. The Medical Director will also assist the Sr . Medical Director in the ... therapeutic area, help develop PRO and biomarker strategies. Relationships Reports to: Senior Medical Director Work with the Clinical Operations, Non-Clinical… more
- Bristol Myers Squibb (Summit, NJ)
- …etc.) to ensure all materials, equipment, and processes are compliant. Support the Senior Director in developing productivity with the cross-functional team. + ... in their personal lives. Read more: careers.bms.com/working-with-us . **Title:** **Associate Director , MS&T Site Lead** **Location: Summit, NJ** At Bristol Myers… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …associated tech transfer business processes. This position will report into the Senior Director of Manufacturing Science and Technology, Parenteral MS&T and ... Practices. The role will also be responsible for review and authoring of key CMC submissions, along with setting relevant standards and creating /maintaining… more
