- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position SummaryThe Technical Data Reviewer reports to the Data Review Supervisor or quality management (ie, Manager or Director). The reviewer will be ... with Raw Material, Finished Drug Products, Stability and Microbiology testing. Data Review may include release, raw material, and stability data and laboratory… more
- BioAgilytix (Durham, NC)
- …ResponsibilitiesPerform Quality Control (QC) technical, scientific, and compliance review of data and documentation generated by the Bioanalytical ... OOS and OOT associated with Bioanalytical Operations data as applicableIssue QC review observations and work closely with the scientific staff to ensure data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …standards for continuous improvement and operations excellence. This may include the review of business partner SOPs and participation in QA initiatives.Partner and ... continuous process improvement activities within QA, as necessary.Participate as a Quality Reviewer for Health Authority inspections in the US, in collaboration with… more
- Merck & Co. (North Wales, PA)
- …to the Director/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and ... objectives.Serve as the liaison and manages correspondence with FDA's promotional review divisions Office of Promotion and Advertising Review (OPDP)/Advertising… more
- Genmab (NJ)
- …clinical development plan (CDP) Author components with Medical Director and reviewer of clinical and regulatory documents and registration dossiers (ie, protocol, ... database lock activities). Lead the development of medical data review plan (MDRP), perform ongoing data review ,...data review plan (MDRP), perform ongoing data review , and summarize efficacy and safety data for interpretation/analysis… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …development and implementation of strategies to maintain efficient and compliant Promotional Review Board (PRB) process Serve as a primary regulatory advertising and ... promotion reviewer for assigned products Liaison with OPDP regarding advertising...or related field required, with 5 years of promotional review experience preferred Advanced knowledge of pertinent FDA regulations… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and document issuance and reconciliation.Key Responsibilities Serve as a Document Control reviewer for new and revised procedures and documents to ensure compliance ... system users with workflow handling and electronic system usageManage the periodic review process for proceduresIssuance of batch related documentation in support of… more
- Merck & Co. (Millsboro, DE)
- …training and oversight of the animal care staff, serving as a designated reviewer and voting member of the Institutional Animal Care and Use Committee (IACUC), ... capital projects.Develop and monitor annual spend and capital budgets.Compose, review , edit institutional SOPs.Establish and maintain departmental policies and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and maintenance of the CCDS, US and EU labeling, and manages the review of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance with ... the cross-functional and cross- regional representatives on the labeling review teams as well as with business partners to...to other project team GLLs and to cross-functional labeling review team members. Responsible for the broad oversight of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and maintenance of the CCDS, US and EU labeling, and manages the review of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance with ... the cross-functional and cross- regional representatives on the labeling review teams as well as with business partners to...to other project team GLLs and to cross-functional labeling review team members. Responsible for the broad oversight of… more
- Insmed Incorporated (San Diego, CA)
- …teams, contract research organizations (CROs), and external vendors to prepare, review and finalize clinical study documents and plansContribute to scientific and ... design planning through final reporting of results Provide scientific input and review of clinical study data, support in assessing medical monitoring reports, study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review Plan (IDRP)Accountable for the ... medications when neededAddresses medical questions directly from sites/ Institutional Review Boards (IRBs), and other site personnel as neededStudy-specific subject… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …experience via benchmarking, customer feedback, auditing and active call monitoring Review contacts handled by external vendor agents to ensure proper identification ... Safety system case evaluation, retroactive call listening, call transcription review , email case review , postal mail case review , agent screen recording… more
- Merck & Co. (Rahway, NJ)
- …to identify inventory at risk and present results to Senior Management. Perform a review of our Company's top key products in order to understand inventory trends. ... from Supply Chain Management to identify matters affecting inventory levels Review inventory footnote and work with consolidation/accounting standards to ensure… more
- Aequor (Framingham, MA)
- …operations to ensure a culture of continuous compliance. Perform batch record review . Perform quality inspections of intermediates and finished goods. Perform ... review of QC data. Perform logbook review . Provide on the floor (OTF) support to the operations department, including OTF support for critical operations Conduct … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study problems.Responsibilities- Protocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, ... for complex studies including study design, protocol development, CRF review , SAP development, analysis files development, statistical analysis accuracy validation,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Regulatory Intelligence (PVRI) and dissemination across CSPV stakeholders. Participates in the review and management of monthly, quarterly, and ad hoc PVRI reports ... PV relevant contracts. Oversee and set standards for PV contract management. Review contribute to revision of DSI contracts (eg development, license, distribution… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Under the direction of the labeling leadership, the manager will develop, review and revise labeling for FDA submission, create and modify Structured Product ... listing, track and archive affiliate labeling for global products and review proposed labeling from affiliates. Responsibilities Provide Regulatory support in the… more
- Daiichi Sankyo, Inc. (Bernards, 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. (Bernards, NJ)
- …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
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