- 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
- 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
- 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
- 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
- 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)
- …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
- Twist BioScience (South San Francisco, CA)
- …ERP systems, and other enterprise applications using MuleSoft, Workato, and related platforms. Lead technical design sessions, review design and code, and ensure ... specializing in Salesforce (SFDC) and systems integrations to join our technology team locally at the South San Francisco, California office. The ideal candidate… 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
- 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. (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
- Merck & Co. (Millsboro, DE)
- …with applicable USDA regulations and is within the Global Regulatory Affairs Bio team . This position is based in the US however closely working together with ... the GRA team located in the EU. In this role, you...submission include but not limited to label packaging, reports/protocols/raw data , individual study summaries (ISS), outlines of production and… 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
- 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
- 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)
- …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
- Merck & Co. (Millsboro, DE)
- …late-shift activities to support the Sterile operations and Logistics Integrated Process Team (IPT) up to and including Central Services, Media Preparation, and ... and revise processes and procedures against corporate and regulatory policies. Review production records for completeness and compliance to departmental and/or… more
- Formation Bio (New York, NY)
- …organization, adapting style to different audiences and simplifying complex information. Lead productive team meetings, fostering collaboration and ensuring ... are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team… more
