- Merck & Co. (Rahway, NJ)
- …, clinical , and commercial) and cGMP industrial background.Experience with design of IV and SC drug products including drug-device combination products for ... biologicsExperience with process design and/or scale-up in the clinical or...product development to commercialization.Demonstrated leadership skills and organization design (ie building high performing teams, building talent, and… more
- Merck & Co. (Rahway, NJ)
- …assembly specifications with sound justification.Understand medical device/delivery system product design , functionality, storage, and handling requirements ... testing using tensile tester or other laboratory equipment and analyze data to inform process development activities.Assist clinical manufacturing team… more
- Formation Bio (New York, NY)
- … product teams. These predictive models will seamlessly integrate with our Clinical Development processes, directly impacting trial design and execution. This ... outcomes with validated examples Demonstrated success in partnering with engineering/ product teams to productize data science capabilities Exceptional… more
- Eisai, Inc (Nutley, NJ)
- …continuing education initiatives including treatment landscape training (disease state and Eisai product data , pre- clinical data , experiential training, ... to prepare medical affairs personnel to enter strategic and compliant discussions regarding medical/ clinical data on Eisai products. The AD assumes a leadership… more
- Merck & Co. (North Wales, PA)
- …value and Implementation teams under clinical development to ensure all clinical trials include the appropriate design input needed for successful ... reimbursement and ensure alignment across Clinical , as well as with Commercial teams on pricing...as with Commercial teams on pricing & reimbursement strategies, product positioning and impact assessments of competitive pricing/access activities.… more
- Merck & Co. (North Wales, PA)
- …affiliates to obtain in-depth understanding of country specific HTA/reimbursement needs for the product and gain input on research design and implementation of ... of the worldwide template document including global value dossier and input forms, design of data collection forms for customization to countries, and in… more
- Merck & Co. (Rahway, NJ)
- …developing, and scaling-up the formulation, device, and manufacturing process.- Driving drug product design from the benchtop to current Good Manufacturing ... Innovation, Mentoring Staff, Operating Models, People Leadership, Pharmaceutical Development, Product Design , Product Development, Regulatory CMC,… more
- Merck & Co. (Rahway, NJ)
- …(FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply ... authoring GMP standard operating procedures and protocols in support of sterile clinical drug product operations. This individual will leverage leadership skills… more
- Insmed Incorporated (San Diego, CA)
- …ranging from purification development and optimization, process characterization and clinical manufacturing investigation support. As part of this collaborative ... you.ResponsibilitiesExecute technical strategies for purification process development to support pre- clinical and clinical programs at all development stages,… more
- Merck & Co. (Rahway, NJ)
- …be programmed, an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM ... Specific Required Skills and Experience: Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH;… more
- Merck & Co. (Rahway, NJ)
- …project digital programs.Responsibilities include:Planning and allocating resources for cross- product delivery and coordinating with investment Manager to ensure ... build a high-performance engagement model with DSCS.- Assist with strategic design and user-centric problem discovery efforts.Collaborate with DSCS Digital Teams to… more
- ResMed, Inc. (San Diego, CA)
- …plans, and patient monitoring dashboards. Collaborate with cross-functional teams including product , engineering, clinical informatics, and data science. ... join our Global UX team. In this role, you'll design digital experiences that directly improve clinical ...HCI, or equivalent professional experience as an interaction/user experience designer OR Master's Degree in design , HCI/Cognitive… more
- Merck & Co. (North Wales, PA)
- …be programmed; an understanding of statistical terminology and concepts Familiarity with clinical data management concepts Experience in CDISC and ADaM standards ... Specific Required Skills and Experience: Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH;… more
- BioAgilytix (San Diego, CA)
- …them.The Manager II will lead scientific and operational activities in support of preclinical, clinical , and product release studies for our San Diego lab. This ... team(s) developing and validating bioanalytical assays for support of preclinical, clinical and product release studies.Motivating team by inspiring employees… more
- Eisai, Inc (Exton, PA)
- …new products in development through their lifecycle (Preclinical through phase III clinical development) at the Biologics Pilot Plant as well as supporting ... Operations groups to support the supply of DS/ADI for pre- clinical and phase I to phase III clinical...Lead and assist in troubleshooting upstream and downstream process, product , and equipment issues and deviations. Provide timely reporting,… more
- BioAgilytix (Durham, NC)
- …using chromatographic and mass spectrometric (LC/MS) techniques in support of preclinical, clinical , and product release studies. Design , plan, and execute ... we tackle challenges across the spectrum of drug discovery to clinical diagnostics, driving advancements that shape the future of healthcare.Essential… 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
- Eisai, Inc (Nutley, NJ)
- …Agility, Customer Engagement, Marketing Fundamentals, Mentoring/ People Development, Omnichannel Strategy, Product / Business Knowledge, Project Mgmt. / Data ... Market Access, Eisai Patient Support, and our Specialty Pharmacy partners in the design and delivery of this solution.Partner in the ongoing monitoring of current… more
- Insmed Incorporated (San Diego, CA)
- …Engineer will play a key role within the Manufacturing Sciences Department, supporting clinical GMP drug substance and drug product production and quality ... lab, with emphasis on commissioning, qualification (C&Q), validation, and equipment reliability. Design , procure, and upgrade QC equipment to align with site needs;… more
- LanceSoft (Northridge, CA)
- …and become proficient in domain knowledge. Working knowledge of diabetes therapy, clinical data , business plans and competitive products. Medical device and/or ... Workshop Facilitation JOB DESCRIPTION As a User Experience Content Designer on the Customer Centered Design team,...the lens of language, collaborating with the UX content design lead, UI/UX designers, user researchers, clinical … more
