- Insmed Incorporated (San Diego, CA)
- …Manage and provide oversight on multiple projects simultaneously. Coordinate and lead validation activities with internal stakeholders and project team ... strategic leadership and decision making on CSV strategy Develop risk-based validation strategies for system implementation and changes following CSV SOPs and… more
- Merck & Co. (Rahway, NJ)
- … clinical and commercial combination product development and launches.Principal Responsibilities: Lead and set direction for the device development strategy for ... development programs ranging from concept generation/selection, development, verification, and validation to launch readiness: Lead the cross-functional Device… more
- Christus Health (Carrollton, TX)
- …and leadership on quality assurance and testing initiatives. Demonstrates ability to lead team through complex integrated testing processes. Able to manage testing ... recommendations and practice. Applies advanced level understanding of assigned clinical /business operations, processes, and workflows. Discusses, and identifies dependencies… more
- Insmed Incorporated (NJ)
- …of a Bachelor's Degree in Computer Sciences, Engineering, or related fieldProject lead experience preferred.Strong experience in Clinical Study Systems is ... periodic reviews, and audit trail reviews.What You'll Do: Develop risk-based validation strategies for system implementation and changes following CSV SOPs and… more
- Insmed Incorporated (NJ)
- …to oversee cybersecurity operations, enterprise risk management, and Computer Systems Validation (CSV) program. This role will manage cross-functional teams and ... with NIST and FDA data protection standards.Partner with Legal, Compliance, Clinical Operations, Quality and R&D to proactively manage risk across Insmed's… more
- Eisai, Inc (Exton, PA)
- …release and stability testing activities; direct product characterization and assay validation . The individual may be required to perform hands-on testing in ... The person will author protocols; reports; author and revise SOPs and lead investigations into assay failures, OOS/OOT events; direct the implementation of CAPAs… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Merck & Co. (South San Francisco, CA)
- …a clinical insight into the earliest stages of target identification and validation , and executing clinical studies to evaluate the relevance of potential ... clinical strategy for novel Immunology assets and therapeutics including authoring initial clinical and biomarker plans for Lead Optimization programs, early … more
- BioAgilytix (San Diego, CA)
- …life-saving therapeutics to the patients who need them.The Manager II will lead scientific and operational activities in support of preclinical, clinical , ... and metabolite profiling/ID. You'll guide a team of scientists through assay development, validation , and sample analysis under GxP, while also playing a key role in… more
- Christus Health (San Antonio, TX)
- …your application. Summary: The competent Nurse, in the same or similar clinical setting, practices independently and demonstrates an awareness of all relevant ... Continues to develop the ability to cope with and manage contingencies of clinical nursing. Makes appropriate assignments and delegates to other care providers as a… more
- Christus Health (San Marcos, TX)
- …is a Certified Chest Pain Center and an accredited Primary Stroke Center. We lead the region in da Vinci robotic-assisted surgery and offers a variety of specialty ... and more. Summary: The competent Nurse, in the same or similar clinical setting, practices independently and demonstrates an awareness of all relevant aspects… more
- Christus Health (San Marcos, TX)
- …is a Certified Chest Pain Center and an accredited Primary Stroke Center. We lead the region in da Vinci robotic-assisted surgery and offers a variety of specialty ... and more. Summary: The competent Nurse, in the same or similar clinical setting, practices independently and demonstrates an awareness of all relevant aspects… more
- Christus Health (Shreveport, LA)
- …information below. Summary: The competent Nurse, in the same or similar clinical setting, practices independently and demonstrates an awareness of all relevant ... Continues to develop the ability to cope with and manage contingencies of clinical nursing. Makes appropriate assignments and delegates to other care providers as a… more
- Christus Health (Kingsville, TX)
- …are in balance. Summary: The competent Nurse, in the same or similar clinical setting, practices independently and demonstrates an awareness of all relevant aspects ... Continues to develop the ability to cope with and manage contingencies of clinical nursing. Makes appropriate assignments and delegates to other care providers as a… more
- Aequor (Thousand Oaks, CA)
- …uninterrupted supply of consistent high-quality critical reagents. End-to-end ownership: Lead projects through definition, pilot, validation , SOP documentation ... medium-to-large improvement projects from problem definition through vendor/technology evaluation, piloting/ validation , SOP generation, and handoff into operations while also… more
- SOFIE (Totowa, NJ)
- …of nuclear medicine! SOFIE is seeking a Product Development Specialist to lead the development, implementation, and validation of manufacturing and analytical ... based on experience and education) Overview The Product Development Specialist will lead the development, implementation, and validation of manufacturing and… more
- Genmab (NJ)
- …us!The Role The Senior Manager, Biostatistics acts as a biostatistician supporting the clinical development of compounds as compound lead , primarily up until ... proof of concept, and/or as trial responsible statistician.ResponsibilitiesCompound/Indication LevelAct as lead and main point of contact related to Statistics for… more
- Merck & Co. (Rahway, NJ)
- …with working closely with the group Director to define group strategy and to lead a team of scientists in solving complex analytical problems at the interface of ... and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process development -… more
- SOFIE (Totowa, NJ)
- …on experience and education) Overview The Product Development Specialist will lead the development, implementation, and validation of manufacturing and ... make an immediate difference? Step into a position that allows you to lead groundbreaking product development in a rapidly growing industry Job Description | Product… more
- Merck & Co. (Rahway, NJ)
- …DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS) organization, the Digital Project Manager will streamline ... execution and management of DSCS Digital initiatives.Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development,… more
