- Novo Nordisk Inc. (Plainsboro, NJ)
- …Product Evolution Oversee product strategy and regulatory activities related to new clinical data or label changes. Lead modification to marketing strategies to ... embark on shaping our future. The Position The Rare Bleeding Therapeutic Area Lead is instrumental in shaping and executing NNI's strategic direction and initiatives… more
- Twist BioScience (South San Francisco, CA)
- … Governance solution and ensure it works seamlessly.What You'll Be Doing Establish and lead the master data governance processes for Twist Operations ... The Sr Master Data Mgmt. Specialist is responsible...The Sr Master Data Mgmt. Specialist is responsible for design and...design and optimization of end to end SAP core Master Data Governance process at Twist. Including… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... you in? Are you ready to experiment with us? The Position The HCP - Strategy Lead (MASH) lead will be a pivotal driver in shaping an insights-driven HCP… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Summary The Oncology Early Development Center (OEDC) Program Lead , who directly reports to the Head of the OEDC, supports the OEDC ... innovative, science-driven portfolios with an equally robust and agile infrastructure. The Program Lead plays a central role in supporting OEDC to drive strategy and… 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
- Merck & Co. (North Wales, PA)
- …or post-market commercial manufacturing vaccines and biologics. - Technical scope: Lead the hands-on execution of upstream pilot-scale experiments. Typical unit ... Coordinate staffing, inventory, waste management, equipment upkeep, budget management, data analysis, and documentation. Mentor other scientists as a subject-matter… more
- Merck & Co. (Lenexa, KS)
- …Global Animal Health Enterprise, as the Global Digital Commerce Acceleration and Performance Lead , you will be a subject matter expert, responsible for owning and ... translate this into Commercial Initiatives. You will be able to operationalise data , insight, and learnings, connecting with the business to improve performance and… more
- Merck & Co. (South San Francisco, CA)
- …experience in complex cellular model/assay development, mechanistic pharmacology, and lead discovery support to join our Quantitative Biosciences (Pharmacology) ... evaluate, and champion new enabling technologies and methodsEnsure high-quality data analysis and timely report generation to project teamsProperly document… more
- Merck & Co. (South San Francisco, CA)
- …PK/PD Director is an expert mathematical modeler and scientist who can lead development of and supervise others in modeling strategy for drug discovery. ... model-informed drug discovery and translational science;Integrate in vitro & in vivo data into systems models (PBPK, PK/PD, mechanistic models) of drug disposition… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions, including but not limited to briefing ... disciplines within the Daiichi Sankyo organization to obtain and/or provide information/ data for regulatory filings.Strategize and plan for FDA meetings for assigned… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of responses to comments from ... support of business objectives.ResponsibilitiesPreparation of new and updated Core Data Sheets, EU and US Documentation: As the project... Sheets, EU and US Documentation: As the project lead , Independently or through direction of a team of… 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 ... BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of responses to comments from ... support of business objectives.ResponsibilitiesPreparation of new and updated Core Data Sheets, EU and US Documentation: As the project... Sheets, EU and US Documentation: As the project lead , Independently or through direction of a team of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position drives/leads the maintenance ... complies with all applicable regulations and guidelines and with Company Core Data Sheets and manages deviations. This position interacts across the RA function… more
- Twist BioScience (South San Francisco, CA)
- …that all customer service issues are resolved promptly and effectively.Responsibilities: Lead and manage initiatives professionals to ensure the timely, effective, ... to track and improve customer satisfaction.Analyze customer complaints and incident data to identify trends and root causes.Collaborate with technical support… more
- Aequor (South San Francisco, CA)
- …fit-for-purpose wet lab-based investigation to address target safety assessment, lead optimization and issue mitigation by employing state-of-the-science in vitro ... is expected to make detailed observations related to experiments, perform, analyze data and interpret results. They will contribute with scientific insights and also… more
- Merck & Co. (Rahway, NJ)
- …include: Lead the development of communication strategies grounded in data insights, ensuring all corporate messaging and engagement initiatives align with ... high-stakes situations.Required Experience and SkillsBachelor's degree in marketing, communications, business, data science or a related field; master 's degree… more
- Genmab (Plainsboro, NJ)
- …adhering to well-architected-frameworks and delivery standards for excellence in execution. You'll lead a skilled team, with the potential to expand, focusing on ... and document reference architecture for various R&D systems and functions.Provide data architecture skills to support core solution architecting and integration of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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, ... within the Daiichi Sankyo organization to obtain and/or provide information/ data for regulatory filings.Review and interpret regulatory guidelinesContinuing Education:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …according to agreed quality standards and timelines and that quality of data is suitable for regulatory submission.The Associate Director will have routine ... primary accountability for operational study-level timeline, cost, and quality deliverables. Lead the development of the clinical study plan including critical… more
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