- Legend Biotech USA, Inc. (Raritan, NJ)
- …treatment of multiple myeloma. Legend Biotech is seeking a Lead QC Microbiology Data Reviewer as part of the Quality team based in Raritan, New Jersey. Role Overview ... The Lead QC Microbiology Data Reviewer is an exempt level position with responsibilities for...commercial operations in a controlled cGMP cleanroom environment. Create, review and approve relevant QC documents, logbooks, SOP's and… more
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …safety, including project-specific training and coaching of team members and review of team output cross-functionally.- Effectively represent the CSPV on the ... providing the safety leadership and serving as the primary point of contact.- Review and analyze data from clinical trials, post-marketing and other relevant sources… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …allocation, budget allocation, and assessment of needs including training, data review tools, etc.Standing PRG reviewer for mid-to-late-stage asset protocolsCore ... documents (writing of ICF, DM charter, response assessment charter, etc), clinical data review excellence with a focus on patient safety and data integrity, site… more
- BioAgilytix (Boston, MA)
- …II/III will perform responsibilities of a traditional lab analyst, peer reviewer , and new system implementation specialist. Tasks will encompass running assays, ... analysis projectsTroubleshoot assaysCompile/process data (make power export)Prepare summary tablesPeer review raw dataOrder reagentsParticipate in assay development and validationResponsible… 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), ... our systems such as Reliance, Atlas SRM, WorkDay, myLearning, eTime, Inspire.Compose, review , edit institutional SOPs.Serve as the hiring manager and trainer for… 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 ... standing by not exceeding the Novo Nordisk points threshold assigned based on review of Motor Vehicle Records. 35 - 50% overnight travel required. Qualifications… 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)
- …compliant with regulatory requirements, including CDISC ADaM data set specifications, reviewer 's guides, etc- Global Biostatistics Data Management (BDM) Strategy to ... Improve Drug Development: Leads implementation of vision and strategy, and identifies technology needs for the function to improve the harmonization and efficiency which leads to cost savings and accelerated worldwide product submissions and approvalsAuthors… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …compliant with regulatory requirements, including CDISC ADaM data set specifications, reviewer 's guides, etc.- Global Biostatistics Data Management (BDM) Strategy to ... Improve Drug Development: Leads implementation of vision and strategy, and identifies technology needs for the function to improve the harmonization and efficiency which leads to cost savings and accelerated worldwide product submissions and approvals. Authors… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …is responsible for the overall quality of materials subject to Product Material Review Process (PMRP) - including but not limited to: Brand sales materials, Training ... the brand teams as well as the Product Material Review Team (PMRT) with the Legal, and Medical Affairs...needed for PMRP and assist with the scheduling and review of PMRP for Global submissions. This individual will… more
- Catalent (San Diego, CA)
- …Title: Quality Assurance Associate, Analytical City: San Diego State : CA JOB DESCRIPTION: Review of analytical release and stability data, involving review of ... (PXRD), Thermogravimetric analyzer (TGA) and Differential Scanning Calorimeter (DSC). Review Hardness testing and Friability of tablets, Content Uniformity and… more
- Merck & Co. (North Wales, PA)
- …of escalated complex global HCP inquiries, and insight generation/analysis), Medical Review of US and HQ-created global Promotional Materials and Scientific Content, ... international congresses to verbally answer unsolicited inquiries from HCPs.Scientific/Medical Review of US and Global Promotional and Non-Promotional Materials:… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …design, participate in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) review - Conducts clinical data review per Integrated Data Review ... medications when needed- Addresses medical questions directly from sites/ Institutional Review Boards (IRBs), and other site personnel as needed- Study-specific… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …case processing activities, which include the receipt, documentation, triage, case review , and quality assessment of all inbound safety information, including ... initiatives/activities, social/digital media monitoring services, and Registries incl. contract review and negotiation, with management of SDEA requirements, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to timelines, budgets, project, and quality plans, and relevant ICH/GCP Guidelines Review protocols to ensure designs are implementable to efficiently achieve the ... Access Program (MAP)/(EAP)Support the oversight of the overall global oncology review process of PhIV company sponsored studies per the Standard Operating… 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 ... on various advisory committees Oversees Veeva Vault Submissions for internal review process with Medical and Legal teams Manages relationships with external… more
- AAOS (Rosemont, IL)
- …the General Counsel, the Associate General Counsel provides corporate legal advice and review , research, and analysis on a wide variety of topics. Administers the ... Center Property Owners Association (affiliated entities). Conducts the primary, initial review of department contracts, creates initial drafts when there are… more
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