- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Data Surveillance, targeted source document verification and targeted source data review . Lead the team to develop and implement metrics including ... disciplines and cultures. Must have technical knowledge on integrated data review and derivation/interpretation of metrics that...activities.- Technical: Provides technical guidance in Quality by Design. Lead the team to define Critical to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or medical lead and biostats to ensure availability of necessary data - Coordinate author review /approval internal review approval- Abstract/manuscript ... Therapeutic Area and respective products.- Lead and facilitate Joint Publication Team discussions as needed. Coordinate author review /approval and internal … more
- Genmab (NJ)
- …and investigator meetings if/as neededCollaboration with Genmab Global Drug Safety:Participate in definition, review , and approval of data packages for Data ... expert supporting the clinical development of compounds as compound and/or indication lead for both early and late-stage programs, and/or as trial responsible… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …under the direction of the Senior Director, GMA Oncology (Global Medical Affairs team lead for compound), is responsible for assisting with defining ... review of investigator-initiated studies (IIS) and may serve as deputy compound lead in Global IIS Review Committee meetings.- Leads selecting medical… more
- Genmab (NJ)
- …reports, as applicable Perform exploratory analysis, ad hoc analyses, and modelling of data Review and approve randomization and stratification plans Perform UAT ... as a biostatistician supporting the clinical development of compounds as compound lead , primarily up until proof of concept, and/or as trial responsible… more
- Merck & Co. (Rahway, NJ)
- …are manufactured in compliance with cGMP and regulatory filings. Perform independent quality review and approval of batch records, testing data , and related ... Global Development Quality Operations - API, is responsible for independent review and approval of documentation to support Good Manufacturing Practice (GMP)… more
- Merck & Co. (North Wales, PA)
- …may include:Serving as the lead clinical scientist on the clinical trial team .Leading medical monitoring team in review and interpretation of clinical ... and scientific acumen as part of a global, cross functional team .Job ResponsibilitiesResponsible for leading specific aspects of clinical/scientific execution of… more
- Merck & Co. (Rahway, NJ)
- …and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design ... and requirements for all dosage forms (liquid, lyo, drug-device combinations) Review and approval of data and technical...and shown to be able to motivate, influence scientific team ; lead by example through past scientific… more
- Merck & Co. (North Wales, PA)
- …coordinates, and provides biostatistical support for drug projects under the supervision of management.- Lead a team of staff assigned to the project as ... knowledge of statistical methodology, experimental design, computing software and data management; a general understanding of worldwide regulatory requirements; and… more
- BioAgilytix (San Diego, CA)
- …and mitigating potential problems and handling disputes calmly and fairlyPresent data and posters.Conduct group team meetings to understand employee's ... and evaluating results. Identify new analytical techniques and technologies and lead their implementation. Review analytical instrument and equipment calibration,… more
- Genmab (NJ)
- …collaboration with cross-functional trial teams to manage timelines, facilitate meetings, and lead review cycles.Provide expert peer review and editing ... impact in oncology drug development and be part of a dynamic, collaborative team that values innovation, quality, and scientific integrity? At Genmab, we are seeking… more
- Merck & Co. (Durham, NC)
- …problem solving sessions to support investigations and develop appropriate CAPAs which lead to program improvements. Review and approve out of tolerance (OOT) ... Engineer is a member of the Engineering, Maintenance and Site Services (EMSS) team providing support to the Durham sites.- This includes Energy Center, Vaccine Bulk… more
- Merck & Co. (Rahway, NJ)
- …clinical trial team . Leading medical monitoring team in review and interpretation -of clinical data /medical protocol deviations in collaborations with ... and scientific acumen as part of a global, cross-functional team . - Job Responsibilities - Responsible for leading...Study Manager on study deliverables. Ensuring CRF design supports data collection in alignment with the protocol in collaboration… more
- Aequor (Houston, TX)
- …(PR) Subject Matter Expert (SME), Level I, for the Warehouse / Supply Chain team Responsible for all Level I key accountabilities: o Responsible for the initiation, ... from stakeholders on the compiled final report o Displays ability to gather data from various sources across the site, performance of Root Cause Analysis (RCA)… more
- Merck & Co. (Durham, NC)
- …problem solving sessions to support investigations and develop appropriate CAPAs which lead to program improvements. Review and approve out of tolerance (OOT) ... Calibration is a member of the Engineering, Maintenance and Site Services (EMSS) team providing support to the Durham sites.- This includes Energy Center, Vaccine… 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 ... Reviews Externally Sponsored Research (ESRs) and may serve as deputy regional medical lead in Global IIS Review Committee meetings. May serve as medical… more
- Genmab (NJ)
- …for leading the development and maintenance of global labeling documents (eg, Core Data Sheet, USPI, EU SmPC and related patient information) for the Genmab ... portfolio of products. The lead may also be responsible for supporting various regulatory...to develop and maintain labeling documents including Company Core Data Sheets (CCDS), Core Safety Information (CSI), United States… more
- Eisai, Inc (Nutley, NJ)
- …needs.Essential Functions Advance Medical and Scientific Knowledge of the Global Medical Team (45%) Lead Global MSL continuing education initiatives including ... activities as well as congress activities. The position serves as a functional lead on cross functional launch planning and other strategic initiatives for Oncology… more
- Eisai, Inc (Louisville, KY)
- …and interest in coaching and mentoring less experienced MSLs. Ability to lead and motivate team members without a direct reporting relationship.Ability ... with a primary responsibility of engaging in the exchange of scientific data and other medical and/or scientific information with external customers (healthcare pr… 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
