- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. The Director is responsible for developing RWE strategies for assigned product(s) and execution of RWE ... to support medical development, additional (post approval) regulatory and safety needs.Ensure communication/publication strategies for given products and publication/presentation… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you.The Medical Director , US Medical Affairs provides medical leadership for medical affairs strategy, planning and ... communication/publication components of overall medical operating plan. The Medical Director provides strategic development, planning, implementation and oversight of… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Medical Director will provide medical leadership for medical affairs strategy, planning and supportive ... tactics for assigned therapeutic area. Under the direction of the Senior Medical Director , this role will be responsible for working with key stakeholders to develop… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as other research areas centered around rare diseases and immune disorders.Summary The Director , Clinical Safety , will be a product safety lead or ... safety team, and be responsible for overall product safety strategy or specific areas of safety surveillance and risk management, and provide safety … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in R&D as early as possible. This led us to create the Translational Patient Safety Senior Director position, which will have unique exposure to Daiichi Sankyo's ... new group within CSPV. He/she will spearhead developing a culture whereby safety is diligently considered prior to selecting promising candidates (DP0), allowing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.SummaryThis position serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple early-stage ... programs, in order to proactively perform safety surveillance and risk management in partnership... surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s), and cross-functional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative 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… more
- Catalent (New York, NY)
- Account Director , Biologics Drug Substance Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative ... a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and...of our recruitment and on-boarding processes to maintain everyone's safety . The Human Resources teams will communicate all necessary… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Technical Director operates under the guidance of the Executive Director - Global Technology Center and will have responsibility for a key ... members (eg, Project Management, Technology, Maintenance, Automation, Plant Operations and Safety ), Engineering Firms and Vendors to lead projects and progress… more
- Merck & Co. (Rahway, NJ)
- Job Description- The Associate Director operates under the guidance of the Technical Engineering and Technology Directors supporting Line of Business (Biologics, ... & Development Division -Scientists, Maintenance, Automation, Plant Operations and Safety ), Engineering Firms and Vendors to progress deliverables. The Associate… more
- Merck & Co. (Rahway, NJ)
- …The Equipment Development and Facility Engineering (EDFE) Leader position will report to the Director , Engineering and will be a member of the EF Team at the Rahway ... the MACS EDFE Leader include the following:The EDFE Leader role at the Associate Director level will serve as a technical mentor and process team member supporting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , Global Oncology Medical Affairs, Medical Intelligence is responsible for ... and portfolio level decision making eg provide intelligence on SOC evolution, safety and efficacy bars for practice changing treatments, information on novel/early… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(CSL)- Clinical Surveillance: Documents ongoing Clinical Monitoring review of data for safety (with Clinical Safety Pharmacovigiliance) and quality at project ... statistics and study design principles applicable to primary and efficacy and safety endpoints in registrational trials to critically assess study conclusions and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of clinical development,...the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global Head RDPVQA, ... function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure requirements are in place for quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilitiesSummaryThe Associate Director , Global Oncology Clinical Development (GOCD) Functional Excellence supports ... (AESI) educational materialsThis role works cross-functionally to collect / update safety and treatment information that is ultimately provided to educate patients… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets ... (CCDS) for assigned products. This position drives/leads the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products. This position ensures that draft labeling complies… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at the study ... of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal and...writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.Lead the CRO and vendor selection… more
- Merck & Co. (Rahway, NJ)
- …enable and accelerate process and product development and manufacturing and ensure safety and quality of our products. -The successful candidate will be accountable ... with cross-functional development teams to enable pipeline decisions.- The Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... of protocol deviations- Discusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse… more
