- Aquestive Therapeutics (Warren, NJ)
- …information, Patient Prescribing Information, Instructions for Use, Supplement Facts, and Core Data Sheets. Responsibilities: *Serve as the regulatory lead for ... Data Sheet. Ensure compliance with FDA labeling requirements. * Lead interactions with FDA regarding promotional submissions, advisory comments, and enforcement… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Data Review, Data Surveillance, targeted source document verification and targeted source data review. Lead the team to develop and implement metrics ... in supporting RBQM activities.- Technical: Provides technical guidance in Quality by Design. Lead the team to define Critical to Quality factors, select critical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for GDX global and regional projects requiring Validation services and Technical Lead assignments.ResponsibilitiesOversee and manage a team of Validation Leads ... rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development,...21 CFR Part 11, Annex 11, GAMP 5, and data integrity - Required Deep understanding of IT system… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …from group head and provide statistical scientific leadership for clinical trial safety data . Lead the statistical support for safety signal monitoring for ... disorders. Job Summary: Provide leadership and guidance as the lead statistician dedicated to safety on one or more...dedicated to safety on one or more safety monitoring team (s), accountable for all methodological and statistical aspects for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …under the direction of the Senior Director, USMA Oncology (US Medical Affairs team lead for compound), is responsible for assisting with defining ... information and internal education, publications, scientific exchange and external data communication, and stakeholder scientific engagement. Responsible for managing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …will lead the forecasting process supporting the Business Development team through financial analysis and valuation process for investment and other business ... leader for the organization who provides strategic guidance and data -driven insights. Collaborates with and influences franchise teams and...ensure tax collaboration: work directly with the BD project lead as well as legal team to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study integration of an assay into clinical testing (before testing) and once data is ready for CDx submission (after testing)Serve as the Point of Contact ... (PoC) for gathering country/region specific CDx RA requirements from local RA team members (eg from Japan, China, Australia, Canada, Korea etc.)For recruitment in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, protocol profiles, and ... on Project Teams.Responsibilities: Study Strategy: Provides the strategic direction to Biostatistics Data Management & Data Ops for EDC, edit checks, … more
- Merck & Co. (Rahway, NJ)
- …Control and Data Analytics will be responsible for leading a team focused on developing and implementing product control strategies, statistical analysis, and ... significant investigations or events directly, and mentor and coach their team to provide on-going support.Essential Duties and Responsibilities: Lead and manage… more
- Merck & Co. (Rahway, NJ)
- …Research & Development in our Company's Research Labs has an opening for a lead administrative assistant. Candidates must have an interest in and ability to work ... individual to work well with colleagues across sites.Interact with team colleagues and understand administrative interdependencies in work.A working knowledge… more
- Formation Bio (New York, NY)
- …Bio, you will lead one of two critical arms of our Data Science function, focusing on building predictive capabilities that drive our drug acquisition and ... therapeutics while ensuring these capabilities evolve into robust, production-ready systems.Responsibilities Lead the Platform Science arm of Data Science,… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …Biotech is seeking a Scientist as part of the R&D Novel Car Design team based in Piscataway, NJ. Role OverviewWe are seeking a highly motivated and creative ... candidate will be an integral part of our R&D team , whose aim is to research, develop and advance...patients.Key Responsibilities Be able to work independently under minimal supervision. Lead , design and optimize research with aims of exploring… more
- Formation Bio (New York, NY)
- …are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team ... patients faster and more efficiently.About the PositionAs a Principal Data Scientist - Medical Imaging at Formation Bio, you...Scientist - Medical Imaging at Formation Bio, you will lead our efforts to integrate advanced imaging analytics and… more
- Formation Bio (New York, NY)
- …is ideal for someone passionate about building scalable infrastructure at the intersection of data engineering and applied AI. You'll lead efforts to ingest and ... to power retrieval, enrichment, and relationship modeling. Platform Operations & Infrastructure Lead architectural decisions across the data platform to support… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for Rare Disease speaker programs, identifying targeted outcomes and crafting tailored experiences Lead team to establish unmet needs, remove barriers to brand ... and monitors adherence to administrative policies and procedures. Recruit, build and lead a highly effective team Physical Requirements 40-50% overnight travel… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …(USO) AI Center of Excellence. The individual will lead and manage a team of data scientists, including AI/ML experts and statisticians, and is tasked with ... high-performing organization that:Attracts and cultivates essential skills needed for data science and AI, ensuring the team ...and vision.Build and evolve the Data Science team to meet internal and market needs. Lead … more
- Merck & Co. (Rahway, NJ)
- …Process/Equipment Trending, Dashboards, and managing KPI's & Metrics.Proven ability to lead projects, developing teams, and building team self-sufficiency.3 ... responsible for-ensuring reliability and efficiency of site operations through data -analytics.-This role will-assess current state analytics and collaborate with… more
- Merck & Co. (Rahway, NJ)
- …and data scientists to find creative cheminformatics solutions to data , workflow, infrastructure, analysis, and modeling challenges. Lead aspects of ... Description We are seeking an experienced and skilled Cheminformatician and AI/ML data scientist to join the Cheminformatics group within Modeling and Informatics… more
- Merck & Co. (Rahway, NJ)
- …execution of our Company's DSCS Digital Strategy to enable a seamless data infrastructure that drives increased speed, capacity and robustness across organizational ... tactical direction and partner with the DSCS Digital Leadership Team to drive the execution and management of DSCS...with a strong background in the biotech industry to lead digital transformation initiatives. This role will focus on… more
- Merck & Co. (Rahway, NJ)
- …Business Risks, Change Management, Clinical Development, Clinical Research, Cross-Functional Team Leadership, Data Analysis, Detail-Oriented, Drug Development, ... and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings...in a particular area of expertise. - Mentors new team members and supports staff development, as needed. D… more
