- Merck & Co. (Rahway, NJ)
- …such as site readiness, audits, inspections, and CAPAs. Support quality risk management activities as facilitator, project lead and/or quality subject matter ... Arrangements:HybridShift:1st - DayValid Driving License:YesHazardous Material(s):NoRequired Skills:Adaptability, Audits Compliance, Data Analysis, Detail-Oriented, Deviation Management , Employee Training… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of the Novo Nordisk US Operations (USO) AI Center of Excellence. The individual will lead and manage a team of data scientists, including AI/ML experts and ... evolve the Data Science team to meet internal and market needs. Lead a high-performing, collaborative team environment.Core member of the AI Center of Excellence,… more
- Merck & Co. (Millsboro, DE)
- …of submission include but not limited to label packaging, reports/protocols/raw data , individual study summaries (ISS), outlines of production and special outlines). ... for US biologicals filed with local CORA, where applicable. Additionally, may lead in creation of GRA standard international dossiers for US Biologicals.May review… more
- Formation Bio (New York, NY)
- …CI/CD pipelines. Establish standards for data governance, observability, and metadata management . Ingestion & Data Modeling Lead development of ingestion ... passionate about building scalable infrastructure at the intersection of data engineering and applied AI. You'll lead ...of data engineering and applied AI. You'll lead efforts to ingest and transform unstructured and structured… more
- Tris Pharma (Monmouth Junction, NJ)
- …lead for assigned projects regularly reporting status/issues to management , conducts laboratory investigations and recommends appropriate Corrective Action ... New Jersey, Tris has an immediate opening for a Method Validation R&D Senior Scientist ISummary:The Method Validation (MV) Research and Development (R&D) Senior … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... Novo Nordisk requirements in relation to Pharmacovigilance (PV) oversight and deviations management . This role fulfills the PV Oversight function in PV deviation … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... function within the role of Quality Business Partner where requested by management Develops comprehensive, relevant resources (eg training program, FAQs) to enable… more
- Merck & Co. (North Wales, PA)
- …data collection in alignment with the protocol in collaboration with Data Management /Programming.Collaborating cross-functionally to monitor clinical data ... with imaging vendors, clinical outcome assessments, biomarker sample collection and management , and external data monitoring committee.Managing other scientists… more
- Merck & Co. (Rahway, NJ)
- …to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D within Research Laboratories is committed to rapidly delivering ... and engage with the scientific community to influence the field.As a Senior Principal Scientist, you will drive various strategic initiatives and translate… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Novo Nordisk US Operations (USO) AI Center of Excellence (AI CoE). The individual will lead and manage a team of data and AI engineers and developers and is ... Strategy, Data Science, and IT teams to ensure a strong data and technology foundation Engage senior leaders to drive strategic technology transformations… more
- Repligen (Rancho Dominguez, CA)
- OverviewWe are seeking a highly motivated and experienced Senior Engineer to lead multi-product project execution, manufacturing support, and technology transfer ... a Subject Matter Expert for TFF and other bioprocessing manufacturing systems. Lead projects in equipment design, tech transfer, process validation, and facility… more
- Eisai, Inc (Louisville, KY)
- …Thinking & Agility, Healthcare Environment Dynamics, KOL/ HCP Engagement, Medical Data and Insights, Mentoring, Resource Planning & Management , Territory ... you. Job Summary The Medical Science Liaison (MSL) / Senior Medical Science Liaison (Sr. MSL) is a field-facing...primary responsibility of engaging in the exchange of scientific data and other medical and/or scientific information with external… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …development valuations in order to provide strategic guidance to senior management , support commercial and strategic decision making.ResponsibilitiesRevenue ... of the Senior Director, Forecasting & Business Analytics is to lead the forecasting and financial and analytical support of commercial assets. In addition,… more
- Eisai, Inc (Bakersfield, CA)
- …Thinking & Agility, Healthcare Environment Dynamics, KOL/ HCP Engagement, Medical Data and Insights, Mentoring, Resource Planning & Management , Territory ... we want to hear from you. Summary: The MSL ( Senior Medical Science Liaison or Principal Medical Science Liaison)...primary responsibility of engaging in the exchange of scientific data and other medical and/or scientific information with external… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …risk factors with and for other technical departments (eg, Clinical, Medical, Safety, Data Management , Statistics). This position requires skills in working in a ... centered around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring)... Surveillance, targeted source document verification and targeted source data review. Lead the team to develop… more
- Genmab (NJ)
- …quality, and scientific integrity? At Genmab, we are seeking a passionate and experienced Senior Medical Writing Manager to help us tell the story of our science ... in a fast-paced environment, are motivated by high standards, and can lead projects with both independence and collaboration. You're proactive, flexible, and highly… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking a Senior Director, Biologics to lead all Chemistry, Manufacturing, and Controls ... with company goals and global regulatory standards. Team Development Build and lead a high-performing CMC team; foster a culture of ownership, innovation, and… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …proven leadership experience managing technical and validation teams, preferably at Director or Senior Management level - Required 7+ years of strong expertise ... 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
- Aequor (Devers, TX)
- …Champion for the Procurement workstream, owning all related change management activities. Data Migration Support: Support and lead all discussions on data ... Process Lead for Procurement Activities: Serve as the Sourcing Process Data Lead and transactional Subject Matter Expert and drive best-in-class business… more