- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders.SummaryThe Director, Clinical Safety , will be a product safety lead or part of a product safety team, and be ... responsible for overall product safety strategy or specific areas of safety surveillance and risk management, and provide safety leadership including but not… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …DMCs, and Academia. L ine management responsibility of Director/Associate Director Global Safety Lead , Senior Global Safety Scientist(s)/Global Safety ... other cross functional teams. Motivated, collaborative, and science-driven global safety expert who would lead the ongoing assessment of safety profile of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and external stakeholders on important drug safety issues supporting Global Medical Safety Lead . Responsible for safety governance/oversight of Clinical ... diseases and immune disorders. Job SummaryThe position develops the global safety strategy, oversees risk management activities, and recruits and develops staffing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Surveillance and other cross functional teams. Motivated, collaborative, and science-driven global safety expert who would lead the ongoing assessment of ... difference? The Position This role is accountable for developing the safety strategy, major safety deliverables for assigned programs within the US East Coast… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Surveillance and other cross functional teams. Motivated, collaborative, and science-driven global safety expert who would lead the ongoing assessment of ... The Position This leadership role is accountable for developing the safety strategy, major safety deliverables for assigned programs within the US East Coast… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Study Report (CSR). May review tables, listings, and figures (TLF) and CSR safety narrativesMay lead the development and updates of the Investigator's Brochure ... assessment of protocol deviationsDiscusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse… more
- Novo Nordisk Inc. (Durham, NC)
- …& support the progress of directors, managers & teams. The Training & Development Lead will work closely with the production teams. As an added benefit, this ... matter expert (SME) in application of established technical training processes Lead or participate in training development workshops locally or globally Present… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …support of inspecting, packaging and/or labeling pharmaceutical products in compliance with all safety policies, cGMPs, and SOPs. The Group Lead , Finishing will ... Position Summary:A Group Lead , Finishing is responsible for coordinating daily finishing...work in compliance with applicable SOPs, cGMPs, regulatory requirements, safety , environmental and company policiesPerform other duties as assignedRequired… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Aseptic Manufacturing LeadPosition Summary:The Aseptic Manufacturing Lead plays a critical role in overseeing aseptic manufacturing activities. A strong background ... microbiology and experience in aseptic manufacturing are required. The Aseptic Manufacturing Lead will actively participate on the production floor by leading a team… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position SummaryThe QC Microbiology Group Lead will report directly to Microbiology management, (ie, QC-Microbiology Supervisor) and will provide both laboratory ... be responsible for implementing policies and procedures that improve safety and productivity. Job ResponsibilitiesWrite and Implement Standard Operating Procedures… more
- Merck & Co. (South San Francisco, CA)
- …in cell-based model and assay development, mechanistic pharmacology, and lead discovery support to join our Quantitative Biosciences (Pharmacology) department. ... assay protocols, and comply with all laboratory trainings and safety requirements.Qualifications:Education: Bachelor's or Master's in Pharmacology, Molecular/Cell Biology,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and ... of systems development for global informatics systems, ETL and integrations. The Tech Lead must develop and implement informatics systems and programs to support the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... us? The Position The Associate Director will be the lead who is responsible for ensuring that all aspects...ensuring that all aspects of our patient quality and safety operations meets standards. This position requires a highly… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …amendments. Additional medical writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND. Lead the CRO and vendor selection process ... primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan including critical path… more
- Merck & Co. (Durham, NC)
- …people that make our products. We work in the manufacturing plants with a " Safety First, Quality Always" mindset striving for continuous improvement. We work in the ... team of individual contri butor production direct reports including safety , quality, and daily operations ; - E nsure..., Release on Time, Customer service performance , Product Lead Time, etc.) . - - Continuous Improvement -… more
- Genmab (Plainsboro, NJ)
- …of data, and medical input into regulatory documents and presentations.Responsibilities: Lead the development of the program strategy for assigned trials/compounds ... and participate in the development of the clinical development plan (CDP). Lead creation and review of clinical components of key documents, clinical and regulatory… more
- Merck & Co. (Rahway, NJ)
- …Associate Director brings forward strong subject matter expertise to lead studies and evaluations, determine suitability, establish direction, conduct risk ... & Development Division Scientists, Maintenance, Automation, Plant Operations, and Safety ), Engineering Firms, and Vendors to progress deliverables. The Associate… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new ... Distinguished Scientist (Executive Director) and Product Development Team (PDT) Lead , Oncology Global Clinical Development, has primary responsibility for the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other key drivers of enhanced quality.Aligns with the RBQM Risk Management Lead on critical-to-quality factors and study-level critical variables and processes, as a ... including conduct of impact assessments and implementation of changes as required. Lead development and maintenance of RBQM standards such as guiding principles,… more
- Merck & Co. (Durham, NC)
- …in their operational areaRepresent Operations on project teams as needed Communication Lead and support daily (Tier) meetings to facilitate flow of information ... to provide area/process overview information to visitors/auditors upon request. Quality & Safety Compliance Foster strong safety culture on the team through… more
