- Tris Pharma (Monmouth Junction, NJ)
- …and team success.We have an immediate opening in our Monmouth Junction, NJ facility for a Director , Drug Safety . The Director , Drug Safety ... vendors on expedited reports, as appropriate Participates in, and/or leads, key Drug Safety activities including, but not limited to: safety data review,… more
- Merck & Co. (Rahway, NJ)
- …a high degree of technical and project management responsibility. The Associate Director - Process/Facility Engineering position will report to the Director , ... Responsibilities include the following:The process/facility engineer role at the Associate Director level will serve as a technical mentor and process team… more
- Merck & Co. (Rahway, NJ)
- …as needed. The position is also responsible for implementing actions to meet Safety and Environment (S&E) and GMP requirements as well as ensuring facility readiness ... pilot plant. The Facility Lead position reports to the Director of Operations/Head of SSO Pilot Plant and the...experience. Required Experience and Skills: Experience with converting new drug substance process needs to an executable series of… more
- Merck & Co. (Rahway, NJ)
- …drugsAnalyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research… more
- Merck & Co. (Rahway, NJ)
- …company is seeking leadership of our Biologics and Mixed Modalities Drug Product Development teams, responsible for the scientific and technical oversight ... of our small molecule, large molecule, and mixed modalities drug product formulation design, process development, and innovation to establish and maintain a… more
- Merck & Co. (Rahway, NJ)
- …to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory strategy for their ... single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Primary activities include, but are not… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new ... those conducted by key authorities such as the USA Food and Drug Administration, European Medicines Agency, UK Medicines and Healthcare products Regulatory Agency,… more
- Merck & Co. (Rahway, NJ)
- …drugs.Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical ... and dedicated colleagues while developing and expanding your career.The Senior Director (Sr. Principal Scientist) has primary responsibility for the planning and… more
- Merck & Co. (Rahway, NJ)
- …drugs;Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical ... and dedicated colleagues while developing and expanding your career.-- Director (Principal Scientist)has primary responsibility for the planning and directing… more
- Merck & Co. (Rahway, NJ)
- …project management responsibility. The Specialist -Engineering position will report to the Associate Director , Engineering and will be a member of the EF Team at the ... facility which is responsible for interfacing with scientists who are manufacturing drug substance to support early clinical studies, scaling up new chemistries, and… more
- Merck & Co. (Rahway, NJ)
- …responsibility.The Associate Specialist -Operations Support position will report to the Associate Director , Engineering and will be a member of the EF Team at ... Lab team which is responsible for interfacing with scientists who are manufacturing drug substance to enable early clinical studies, scaling up new chemistries, and… more
- Merck & Co. (Rahway, NJ)
- …The Senior Specialist - Manufacturing Automation position will report to the Director , Engineering, Automation Lead position and will be a member of the ... a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned… 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 ...to strategically manage benefit-risk throughout the lifecycle of the drug . Specific responsibilities will vary depending on the stage… more
- Catalent (New York, NY)
- …Global Nutritional & Beauty Business Development Team reporting to the Regional Director Beauty Softgels North America, and responsible for managing new business ... rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring...a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and… 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 ... global drug portfolio from the Research stage to post marketing/lifecycle...within CSPV. He/she will spearhead developing a culture whereby safety is diligently considered prior to selecting promising candidates… 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, ... with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure requirements are in...agencies required- 10+years of working knowledge of the end-to-end Drug development process in the R&D space required- 10+… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary Position leads very complex studies or entire drug project in study design, data analysis and interpretation of results independently ... with minimal supervision. This position provides input to entire drug development plans with minimal supervision and authors regulatory responses and other documents… 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)
- …Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on ... Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at...writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.Lead the CRO and vendor selection… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Team (SMT) materials- Supports overall program safety reporting (eg, Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), ... areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to… more
