- Merck & Co. (Rahway, NJ)
- …with internal and external reviewers, and guiding the posting through review and approval. Collaborating with clinical teams, including requesting necessary data ... Regulation of the European Union). Responding to internal and clinical review comments on public disclosures; amending disclosures as appropriate and incorporating… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CCDS; Ensures implementation of CCDS/labeling agreements with licensing partners.Conduct Label Review Committee Meetings: Prepares documents for review by ... for US, EU and Company Core documents as well as for the review of country labeling deviations.Ensure Compliance with Labeling Regulations and Guidance: Researches… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study problems. ResponsibilitiesProtocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, ... medium complexity studies including study design, protocol development, CRF review , SAP development, analysis files development, statistical analysis accuracy… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …decision. By guiding other internal programmer or by self, perform programmatic review of Study Date Tabulation Model (SDTM) and analysis (including Analysis Data ... submissions. Responsibilities include: make strategic programming decision and planning, review Case Report Form (CRF) annotation and SDTM dataset, identify… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and cross-functional team to develop safety strategy, key safety messages, and review and author safety sections of Common Technical Document (CTD). May oversee ... PSL(s) or Clinical Safety Physician(s) for assigned product(s) or clinical studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and build and … more
- Insmed Incorporated (Bridgewater, NJ)
- …from regulatory authority or EC/IRBs.Provide medical feedback for activities related to review of data for interim analysis or blinded data reviews.Production of ... eg MACE, Potential events related to metabolite, Liver enzymes. Review of mortality cases, evaluation of CIOMS, production of...to address information gaps in CIOMS of such deaths. Review of SUSARs and contact with PIs in each… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Oversight of annual reports Participate in project team meetings as assigned Review data from contributing departments (including NNAS) and provide comments to ... assure accurate and complete documents for inclusion in these applications Review of regulatory strategy documents; eg, provides supervisor with input on regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …specifications as per CDISC SDTMIG.Perform SAS programming to provide complex data review listings and reports to support Data Management and clinical teams.Develop, ... implement and maintain SAS programming standards and performs quality checks. Review annotated case report forms and database structures.Develop reports & graphs in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …needed.Responsibilities- Contract Coordination: Collate exhibits to create contract draft, Review contract documents for completeness and accuracy; Ensure compliant ... Update CLM system/trackers throughout the process.- Conduct simple negotiations review contractual amendments details against original contract. Ensure internal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …strategic and planning alignment across regions and functions and supports review of Local Country/Regional Medical Affairs activities when applicable. Provide ... Clinical Operations and other cross-functional and regional stakeholders.Provides support in review of investigator-initiated studies (IIS) and may serve as deputy… more
