- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you ready to make a difference? The Position Lead the Medical Promotional Review staff and direct their activities, across all therapeutic areas where Novo Nordisk ... Develop and execute the long-term strategy for the Medical Promotional Review team, including solutions for innovation, automation, and optimal resourcing. Serve… more
- Merck & Co. (Rahway, NJ)
- …is seeking a highly motivated Scientist- GMP Microbiology Investigation Support /Data Reviewer to join the growing Microbiology Center of Excellence (COE).- Based at ... utility (environmental/water) deviations. This position will also be required to review GMP microbiological data from product and utility testing. -While working… 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. (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
- 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
- BioAgilytix (Durham, NC)
- …through thorough monitoring and audits. Partnering with the Operations team, you will review key procedures in a GxP environment, with focus on GMP, highlight any ... We are looking for candidates who have large molecule, bioanalytical, data review and preferable QA experience in a deadline-driven and regulated GMP setting.… more
- Insmed Incorporated (San Diego, CA)
- …as medical assessment of individual adverse event reports, generation, and review of aggregate reports and safety documents, including labeling changes.This role ... This position reports to the Vice President, DSPV.ResponsibilitiesLeads the Safety Review Team(s) for assigned products and development compounds, and is responsible… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and reviews IME grant proposals, represents Medical Affairs in Promotional Review Board (PRB) activities including reviewing medical and scientific content of ... Serve as NNI Medical Affairs representative on Medical & Science Team Review and provide comments to trial outlines/protocols for Novo Nordisk-sponsored clinical… more
- Novo Nordisk Inc. (Durham, NC)
- …Novo Nordisk and help us make what matters. The Position Perform quality review & approval of Batch Production Records (BPRs), Change Requests (CR's), Deviations & ... on shop floor. Handle release of raw materials & provides quality oversight, review & approval of validation activities associated with minor changes to existing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …users to roles based on authorized requests from study team members, periodic review of user access and audit trail reconciliation, impact analysis and documentation ... and maintain traceability of data access requests, procedures for the periodic review , and process improvements. This position will also work with members of… more
- Novo Nordisk Inc. (Durham, NC)
- …addressed & handled in close collaboration with production. Main duties include review of batch reports & release of incoming materials, deviations, change controls, ... review & approval of SOPs, QA presence & process...compliant with regulations Has product release authority Quality oversight, review & approval of validation activities associated with projects,… more
- Novo Nordisk Inc. (Durham, NC)
- …Novo Nordisk and help us make what matters. The Position Main duties include review of batch reports & release of incoming materials, deviations, change controls, ... review & approval of SOPs, QA presence & process...compliant with regulations Authority for product release Quality oversight, review & approval of validation activities associated with projects,… 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
- 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. ResponsibilitiesProvide Regulatory support in the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and forecasting for commercial and IMP relevant activities and QA batch review and release process as necessary.Complaint and Recall Programs Establishment: Manages ... external stakeholders to complete deviations in a timely manner.Development and Review of Standards and Procedures (SOPs) and Training Activities: Responsible for… more
- Novo Nordisk Inc. (Durham, NC)
- …transferring, counting, FIFO, returns, etc. Participate actively in & support event response Review & author SOPs & other documents as required Identify, report & ... equipment outside of own expertise (with the appropriate experience & skill level) Record/ review production data in BPR & associated forms Follow all safety &… more
- Aequor (South San Francisco, CA)
- …office or be fully remote *Please submit candidate at market rate for review *During candidates screening please ask candidates to submit the written examples of ... including definition of the appropriate material, instructions, lab manual development & review , kit development, database set up, etc Accountable for ensuring that… more
- Merck & Co. (TX)
- …at product workshops and conferences, as well as consistent and ongoing review of Company promotional materials.Providing Company management with updates on customer ... product workshops and conferences, as well as consistent and ongoing review of Company promotional materials.Regularly monitoring their business performance against… more
