- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Strategic Application product roadmaps to meet business goals and objectives. Lead the definition of solutions based on business needs, cost, and required ... areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Regulatory Lead for asset to reach resolution.Participate in global product team meetings to provide US regulatory support and guidance as needed and ... matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions, including but not limited to briefing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the GCL, if applicableDelivers all relevant components needed for maintenance of product licenses (eg, Core Data Sheet generation/revision; clinical benefit-risk ... UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review PlanAccountable for the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member and independently provides strategic and ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads...Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member and independently provides strategic and ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads...Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position ... Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position drives/leads the maintenance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …stakeholders on important drug safety issues supporting Global Medical Safety Lead . Responsible for safety governance/oversight of Clinical Safety and risk ... for risk mitigation and oversees the global communication of important product safety information.Create and align processes that address global CSPV objectives… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data .Drug Development Strategy: Provides ... sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight: Review CRO/vendor proposal and budget.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for assigned project(s).Strategize and plan for FDA meetings for assigned product . Liaise, negotiate and orchestrate meetings with FDA. Prepare internal meeting ... capture the full discussion for archiving. Serve as the primary contact with FDA. Lead and prepare FDA submissions, including but not limited to briefing documents,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …False Claims Act, Anti-Kickback Statute, OIG guidance, the PhRMA Code, state and federal data privacy laws, and product liability laws) required- 7 or More Years ... as identified by senior management.Responsibilities- Acts as a brand attorney and lead legal advisor for the commercial business and operations supporting US… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data .- Drug Development Strategy: Provides ... scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.- CRO / Vendor Oversight: Review CRO/vendor proposal and… more
- Merck & Co. (Rahway, NJ)
- …with partners and value teams, ensuring strategic alignment across the product line.Discovery and Prioritization: Lead product line-level discovery ... objectives, and ensuring that these are well defined with measurable outcomes.- Product Line Lead , Workplace Services' primary responsibilities include, but not… more
- Merck & Co. (Rahway, NJ)
- …candidate will lead a cross functional insights team that spans data science, market research, data strategy, and measurement.The preferred candidate should ... Job DescriptionThe Associate Director Data Science will be responsible for developing and...be an independent contributor as well as be a lead partner in helping to scope, design, and deliver… more
- Merck & Co. (Rahway, NJ)
- …rigorous scientific and ethical standards.-The Distinguished Scientist (Executive Director) and Product Development Team (PDT) Lead , Oncology Global Clinical ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs...field of m elanoma . The Executive Director, PDT Lead will manage the entire cycle of clinical development,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory activities related to new clinical data or label changes. Lead modification to marketing strategies to encompass product related changes Supply ... our future. The Position The Rare Bleeding Therapeutic Area Lead is instrumental in shaping and executing NNI's strategic...within the TA. This role is responsible for guiding product development and commercialization strategies for late stage and… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, ... collaboration skills.-A strong track record of publications in parenteral drug product development and/or deliveryDemonstrated ability to lead cross-functional… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is ... PositionThe Novo Nordisk Real World Evidence (RWE) / Clinical Data Science & Evidence (CDSE) - Fellow is responsible...identified during the annual EIGP process to support the product strategy; the Fellow may also be involved in… more
- Merck & Co. (Rahway, NJ)
- …scientific understanding and capability builds within the organization.Primary Responsibilities:Responsibilities: Lead development of new, innovative approaches for ... of the drug development processDemonstrated ability to independently design, execute and lead complex experiments and data analysisTrack record of working… more
- Merck & Co. (Rahway, NJ)
- …This role includes the comprehensive preparation and submission of combination product sections for both commercial and investigational products, such as pre-filled ... include, but are not limited to: Serve as the Regulatory Project Lead for assigned device and combination products, guiding cross-functional teams to ensure… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur RaDS IT Research Infrastructure Product Line (RIPL) engineering team is seeking a Senior Specialist - Research Automation OT Infrastructure. This ... position will be a member of the Research Automation Operations product (Laboratory and Plant) within RIPL. -As Sr. OT Infrastructure Specialist, you will lead … more
