- Aequor (South San Francisco, CA)
- Job Title: Senior Taxonomist - Content Review & Management Location: Onsite - South San Francisco (SSF) or Remote Contract Type: 6-Month Contract (with potential ... We are seeking an experienced and strategic Senior Taxonomist to support our Content Review and Management team. This is a 6-month contract role with the possibility… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and biostats to ensure availability of necessary data- Coordinate author review /approval internal review approval- Abstract/manuscript submission with vendor ... support- Facilitate response to journal reviewer comments/requests- Publication tracking and announcement, in coordination with Medical Information Education (ME)-… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the team responsible for QA oversight of final CAR-T product batch record review and release practices.Lead the establishment and improvement of QA practices to ... ensure accurate documentation of all review and release activities, including manual and electronic practices.Establish and implement cGMP procedures to ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategic and planning alignment across regions and functions and supports review of Local Country/Regional Medical Affairs activities when applicable. Provide ... Operations and other cross-functional and regional stakeholders.- Provides support in review of investigator-initiated studies (IIS) and may serve as deputy compound… more
- Merck & Co. (Durham, NC)
- …the production floor, coordination across processing suites, real-time batch record review , execution of aseptic processing requirements as needed, adherence to Good ... include, but are not limited to :- Executes operational review and comment resolution of batch records to include...SAP system discrepancies.- Assists team in real-time batch record review and ensures timely closure of shopfloor orde r.… more
- City of Spring Hill Kansas (Spring Hill, KS)
- …provide expertise related to planning, zoning and codes as part of the development review process. Join us and be part of developing complex and long-range goals! We ... variety of assignments and projects related to the development review process as well as conducting special or long-term...and zoning regulatory controls as well as site plan review to ensure conformity with planning and land-use practices.… more
- Eisai, Inc (Nutley, NJ)
- …the disease state community.Additionally, the Associate Medical Director is responsible for review and approval of medical and scientific content of all relevant ... IV clinical development programs for assigned product(s).Create IIS strategies and review proposals in conjunction with company policies.Participate in review … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(RAAP) will lead and oversee all regulatory activities related to the review , approval, and compliance of advertising and promotional materials for the company's ... marketing, medical affairs, and legal, on the product material review team (PMRT), and will act as the main...resolve regulatory challenges that arise in alliance partner collaborations. Review and Approval of Promotional Materials: Review and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …provide guidance and determine immediate path forward for manufacturing issues.Real time review of all documentation, and reporting, in support of process unit ... operations, in accordance with Good Documentation Practices (GDP). Review , revise, or draft Standard Operating Procedures (SOPs).Support on process aseptic process… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …QA to conduct quality reviews of product profiles, ensuring thorough management review of all quality and compliance topics, including Key Quality Indicators (KQIs). ... appropriate forums, such as Quarterly Quality Reports (QQRs) and Quality Review Boards (QRBs).Collaborate with business process owners to monitor the effectiveness… more
- Eisai, Inc (Nutley, NJ)
- …IV clinical development programs for assigned products.Create IIS strategies and review proposals in conjunction with company policies.Participate in review ... key internal business processes including active participation in relevant medical review committees.Work with key internal stakeholders to support development and… more
- Aequor (Vacaville, CA)
- …These duties include execution of laboratory testing, trend analysis, documentation review , support of discrepancies (OOS, OOT, OOE) and other laboratory support ... of basic and moderately complex tests with documentation according to GMP Review data and assess against established acceptance criteria Perform technical review… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CRF/eCRF design, all steps from database development to database release, data review and cleaning, database lock), to ensure data quality/integrity and regulatory ... programs.- Promotes Risk Based approaches to data cleaning and review - Proactively collaborates cross-functionally during interactions with Regulatory Authorities… more
- Genmab (NJ)
- …learningsRepresents Genmab during Key Opinion Leaders meetings Ensure biostatistician review of partner synopsis, protocols, statistical analysis plans, results ... deviations classifications, DSUR, IB updates, tables, figures, and listings etc. Review assay validation reports, as applicable Perform exploratory analysis, ad hoc… more
- Merck & Co. (Durham, NC)
- …Global Vaccine Technology (GVTE), Automation, and Quality approvers.-Perform a thorough review of design & engineering records and related Good Manufacturing ... in a timely manner, and implementing corrective actions to improve the execution/ review process for equipment.Develop training material. Working as a subject matter… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and dissemination across CSPV stakeholders for impact assessment. Participates in the review and management of monthly, quarterly, and ad hoc PVRI reports received ... Contribute to overseeing and setting standards for PV contract management. Review contributes to revision of DSI contracts under negotiation (eg development,… more
- Eisai, Inc (Nutley, NJ)
- …strategic plan for assigned therapeutic area(s). These deliverables include development and review of compliant scientific exchange materials to be used in external ... and other senior-level medical communication initiatives as needed.Manage and support the review of SEM and internal medical documents through Medical Review … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …process, to ensure information is documented and reported timely.Folder Audit includes: Review HCP Engagements that are considered closed according to the policy ... Head a monthly pass/fail report for performance managementMonthly full file audit includes: Review that all documents are uploaded and in the appropriate section of… more
- BioAgilytix (San Diego, CA)
- …new analytical techniques and technologies and lead their implementation. Review analytical instrument and equipment calibration, qualification and maintenance ... records.Perform statistical analysis.Write and review reports and prepare SOPs.Fulfill the role of Bioanalytical Project Manager (BPM)/Principal Investigator (PI)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …master label text, translations, and label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works ... product distribution activities at the vendor, including generation of drug orders, review of shipping documentation and obtaining approval to ship.Assists in the… more
