- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a QC Data Reviewer as part of the Quality team based in Raritan, NJ. Role Overview The ... QC Data Reviewer is an exempt level position responsible for reviewing...in a controlled GMP environment. Key Responsibilities Perform peer review /approval of laboratory data including but not limited to… more
- BioAgilytix (Boston, MA)
- …the QC reviewsFollow QCT SOPsResponsible for second-level technical reviews of documents prior to review by the project manager (eg, Bioanalytical Project ... II/III will perform responsibilities of a traditional lab analyst, peer reviewer , and new system implementation specialist. Tasks will encompass running assays,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …medical support. Support MLs with ISS development, such as providing independent reviewer support when needed Analysis and translation of insights and Competitive ... by not exceeding the Novo Nordisk points threshold assigned based on review of Motor Vehicle Records. Qualifications Doctorate degree in health sciences (PhD,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure metadata is accurate and submission data is complete for review Review and edit all promotional material prior to PMRP to ensure adherence to ... brands, agencies and PMRP reviewers regarding materials and timelinesPMRT Member Review all materials prior to PMVP submission - consult with other PMRP members… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of this job is to oversee statistical vendor deliverables, perform programmatic review of analysis datasets and Table, Listing, and Figures (TLFs) generated by ... By leading internal programming contractor or by self, perform programmatic review of analysis datasets and TLFs generated by statistical vendor, ensure… more
- Merck & Co. (North Wales, PA)
- …not limited to) the implementation of primary data collection, chart review /survey, database studies, health economic model development and adaptations, dossiers, ... study execution through close-out of primary data collection, chart review , and database studies in addition to other activity...of twelve (12) months of service in current position prior to applying for open positions.If you have been… more
- Catalent (Philadelphia, PA)
- …compliance, and to the safety of every patient, consumer, and Catalent employee. The Role Review and approve all batch records prior to production to ensure that ... Quality Assurance Document Control individual is responsible in preparing customer files, review and approve batch records, and release batch records and finished… more
- Merck & Co. (Durham, NC)
- …direct in-line Quality support for all compliance and environmental monitoring matters, review of atypical events including accessing product impact for EM events, ... providing Quality oversight to alarm events during processing, review and approval of incursions, review and...of twelve (12) months of service in current position prior to applying for open positions.If you have been… more
- Merck & Co. (North Wales, PA)
- …and regulatory submissions including assisting in preparing submissions, protocol review , and conducting research on regulatory guidance's or competitive ... also assist or take the lead in tracking, authoring, shepherding and/or review of responses to Agency requests.Implements strategy to develop agency background… more
- Eisai, Inc (Exton, PA)
- …early to late stage manufacturing programs.This position will be responsible for the review and interpretation of analytical testing data as well as protocols and ... company's discretion. Essential Functions Managing external testing lab collaborations 15% Review and interpretation of analytical data 20%Troubleshooting of analytical… more
- Merck & Co. (Rahway, NJ)
- …and/or subsidiaries for all applications and submissions.Responsible for regulatory review and final approval of all submissions and associated ... coordinates cross-functional regulatory support for development programs and marketed products. Review and provide final approval of local registration study… more
- Lundbeck (Chicago, IL)
- …to measure and evaluate the effectiveness of training and provides metrics for management review Acts as a point of contact for sales and marketing teams regarding ... of existing training initiatives Ensures that all training materials are updated prior to expiration and are built and delivered within compliance guidelines… more
- Merck & Co. (Millsboro, DE)
- …with Guidance from the QC Manager, ensures product/process quality through the review of GMP documentation and performs activities to ensure the efficient testing ... departments in receipt, distribution, scheduling of QC tests, and review and release of antigen and seed batches. The...of twelve (12) months of service in current position prior to applying for open positions.If you have been… more
- Merck & Co. (Rahway, NJ)
- …is: Accountable for HHDDA Taxonomy, Demand Management Tool & Project Approval & Review (PAR): Acting on behalf of Human Health Operating Committee (HHOC) and HHDDA ... and synthesize inputs.Maintain a taxonomy playbook complete with structured business review templates to facilitate tradeoffs / reprioritization discussions with BU… more
- Catalent (St. Petersburg, FL)
- …quarterly and annual summaries and metrics, including DRB (Deviation Review Board) presentation.Effective communication with Quality Assurance Supervisor and Manager ... organization, participating in internal assessments, routine compliance and CAPA review board meetings including follow-up actions and facilitate and conduct… more
- Merck & Co. (Rahway, NJ)
- …AH enterprise application architecture.Design and chair the Animal Health Architecture Review Board (AH-ARB) to facilitate the governance process for architecture ... at least 15 years of related experience.Required Experience and Skills: Prior experience successfully leading major architecture-driven digital transformationsPrior experience… more
- Merck & Co. (North Wales, PA)
- …response to state affordability reviews.Lead response to any state PDAB's affordability review of our Company's Oncology products.Model any risk to the business ... stemming from a state's affordability review and potential Upper Payment Limit implementation.340B: Monitor performance data across identified top accounts to ensure… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …experience in developing and managing a learning program from content to delivery. ** Prior to applying, review the Education & Qualification section - Be sure ... experience, to include leading learning program design efforts required- Prior experience working in Pharmaceuticals Research & Development, Required required-… more
- Aequor (Swiftwater, MN)
- …Future state process mapping Organize, track and plan master data review Track and mange project specific deliverablesQUALIFICATIONS: Secondary Education diploma ... required. University Graduate preferred Prior experience with quality applications,... experience with quality applications, such as Veeva, LIMS Prior experience with MS Word, Excel, Powerpoint, Visio and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …development to market. The candidate is a team player, detail oriented with prior research experience, either in academia or industry. In this role, the incumbent ... programs Serve as a leading member, or participant, at multiple internal review groups and utilize novel and creative methods to resolve clinical development… more
