- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Uses medical knowledge to aid the SMT's signal identification efforts. Safety Expert - Signal Evaluation: Assists manager in assessing new signals. Safety ... sections of the NDA, CSR, and IB. May review any safety submissions for medical accuracy. Qualifications: Successful candidates will be able to meet the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of ... the Technical Operations team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide… more
- Eisai, Inc (Nutley, NJ)
- …Publishing and Registration tracking; Working with Regulatory Planners, Publishers, Safety Officers, Case Processers, Medical Writers, Labelling authors ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides...(which may have been gained concurrently): Supporting Regulatory and/or Safety functions in a global environment; Supporting Regulatory processes… more
- Merck & Co. (North Wales, PA)
- …the Director may be responsible for: Providing scientific and medical leadership for strategic alliances and Co-partnership opportunities.-Supporting the team in ... statistics, and manufacturing to manage clinical development projects; andAssist the Senior Director , Executive Director , and/or Associate Vice President in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets… more
- Insmed Incorporated (Bridgewater, NJ)
- …external stakeholders (therapeutic areas, clinical pharmacology, clinical operations, non-clinical safety , contract research organizations etc.) to build and to ... pet, legal, and supplemental life insuranceFlexible spending accounts for medical and dependent careAccident and Hospital Indemnity insuranceEmployee Assistance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... develop programming submission strategy, perform integrated analysis of efficacy and safety , generate submission data package, create TLFs to support submission QAs,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …advice to the CSPV and key business function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure ... limited to: Global Project Team, Safety Management Team, Clinical Safety and Pharmacovigilance Medical Affairs, Companion Diagnostics/ Device Laboratories… more
