- Merck & Co. (Rahway, NJ)
- …Management Section of the GCS Planning organization. -Working independently, the Inventory Manager Clinical Supplies Project Manager (IM CSPM) creates ... supply chain deliverables and prepares, analyzes, and/or develops mitigation strategies for review with clinical partners and senior leaders. -Responsible and… more
- Merck & Co. (Rahway, NJ)
- …operational/executional arms within the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic ... chain deliverables and prepares , analyses , and/or develops mitigation strategies for review with clinical partners and senior leaders.- - Works directly in… more
- Merck & Co. (North Wales, PA)
- … scientist on the clinical trial team.Leading medical monitoring team in review and interpretation of clinical data /medical protocol deviations in ... in collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality, completeness, and integrity of… more
- Merck & Co. (Rahway, NJ)
- …scientist on the clinical trial team. Leading medical monitoring team in review and interpretation -of clinical data /medical protocol deviations in ... in collaboration with Data Management/Programming. Collaborating cross-functionally to monitor clinical data -to ensure quality, completeness , and integrity… more
- Eisai, Inc (Nutley, NJ)
- … Programming manages and oversees JReview and SAS program development for clinical data processing, data review reports and listings. This includes but ... must be a highly specialized individual contributor or functional manager with advanced knowledge and expertise to analyze assess...of Data Operations, Data Management, Clinical Safety Data Review and… more
- Genmab (NJ)
- …from/to business partners in collaboration with the programmer and the data manager , as applicableCTT member:Participate and represent BiostatisticsReview and ... love to have you join us!The Role:The Senior Statistical Manager acts as a biostatistician supporting the clinical...Perform exploratory analysis, ad hoc analyses, and modelling of data Review and approve randomization and stratification… more
- Taiho Oncology (FL)
- …trials as assigned, which may include providing recommendations for site selection, clinical data presentation at site initiation or training meetings, and ... Taiho products and relevant disease states, and facilitation of clinical research. The Sr. Manager , Medical Field...in scientific exchanges and interactions with identified KOLs Present clinical and scientific data on Taiho's products… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...chair of PV Deviation Board to facilitate the pre-approval review by board members of all NNI Patient Safety… more
- Genmab (NJ)
- …integrity? At Genmab, we are seeking a passionate and experienced Senior Medical Writing Manager to help us tell the story of our science through compelling ... clinical and regulatory documents. You'll be at the heart...trial teams to manage timelines, facilitate meetings, and lead review cycles.Provide expert peer review and editing… more
- BioAgilytix (San Diego, CA)
- …you enable life-changing, life-saving therapeutics to the patients who need them.The Manager II will lead scientific and operational activities in support of ... preclinical, clinical , and product release studies for our San Diego...mitigating potential problems and handling disputes calmly and fairlyPresent data and posters.Conduct group team meetings to understand employee's… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and contracts including vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Manage oversight of DSI contracts that are ... and dissemination across CSPV stakeholders for impact assessment. Participates in the review and management of monthly, quarterly, and ad hoc PVRI reports received… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …/systems SMEs to define reporting needs to oversee process performanceShare and review data /metrics with the GRA Analytics TeamCoordinate the development and ... rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global...Global Regulatory Affairs and cross-functional teams (eg, Quality, CSPV, Clinical Operations, Clinical Development, RA CMC) to… more
- Novo Nordisk Inc. (Orlando, FL)
- …techniques Maintain up to date knowledge of the latest approved scientific and clinical data to engage in meaningful discussions with customers and address ... experience using sales data /call reporting software ideal Mastery knowledge of the clinical management of diabetes and the range of treatment options Must be a… more
- Genmab (NJ)
- … transfers from/to business partners in collaboration with the programmer and the data manager , as applicableEnsures state of the art statistical work which ... and investigator meetings if/as neededCollaboration with Genmab Global Drug Safety:Participate in definition, review , and approval of data packages for Data … more
- Novo Nordisk Inc. (Walnut Creek, CA)
- …required activity records/reports, including timely and accurate transmission of call data Understand the scientific and clinical underpinnings of brand ... Sales Representative also assists their target physicians with their local clinical and educational initiatives by coordinating company resources (eg, counterparts,… more
- Novo Nordisk Inc. (Dayton, OH)
- …assess, create and maintain advocacy of customers aligned to company, brand and clinical goals. The OCS develops local strategies and executes local tactical plans ... The OCS also assists their customers with their local clinical and educational initiatives by coordinating company resources (eg,...health. Internally, the OCS reports to the District Business Manager of the specific sales territory. The OCS also… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …from different disciplines and cultures. Must have technical knowledge on integrated data review and derivation/interpretation of metrics that can dynamically ... variables and processes, and build appropriate mitigations. Drive interface with Integrated Data Review , Data Surveillance, targeted source document… more
- BioAgilytix (Durham, NC)
- …and manage studies in LIMS; maintain accurate laboratory records, worksheets, and raw data with peer review .Train, mentor, and direct junior scientists and ... is seeking a Scientist III to serve as Bioanalytical Project Manager (BPM)/Principal Investigator (PI), overseeing all aspects of bioanalytical studies-including… more
- Novo Nordisk Inc. (Boston, MA)
- …Internally, the Ecosystem Portfolio Specialist reports to the Ecosystem Business Manager . The Ecosystem Portfolio Specialist also must work collaboratively work with ... quality metrics, as needed Ability to view, manipulate and extract actionable insights from data to build and execute a business plan Manage and prioritize time and… more
