- 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. (Durham, NC)
- …established and maintained based on the product strategy. Ensure Organization of short-term review of control charts. Ensure presentation and review of relevant ... data and participate in evaluation of results. This also includes ensuring that relevant actions are carried out and completed. Relationships Manager. The role is responsible for collaborating with stakeholders related to assigned area. Support training for… more
- AUROBINDO (Dayton, OH)
- …and updates essential Laboratory documents as per current regulatory guidelines. Review and Compilation of Analytical Data required for Regulatory filings.Serves ... and cGMP in Analytical Lab.Compilation and trending of Analytical data. Review and preparation of SOPs, STPs, GTPs and Protocols....Review and preparation of SOPs, STPs, GTPs and Protocols. Review / approval of sample login in LIMS and 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
- 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
- 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
- Merck & Co. (Durham, NC)
- …for establishing processes that ensure required safety guidelines are followed. Review and approve qualification/validation documents for equipment and process (ie, ... IQ/OQ/PQ). Review and approve Performance Qualification documents pertaining to environmental...approval of Quality Notifications (QNs) and ChangeRequests (CRs). Author, review , and approve SOPs.Assume project management opportunities, by leading… more
- Merck & Co. (Durham, NC)
- …Company's Quality Management System. Provide QA shop floor support in the execution and review of GMP documentation such as IQ, OQ and other technical documents to ... meet schedule milestones. Provide QA shop floor support on batch review , alarm response, incursion response and deviation management. Provide QA shop floor support… more
- Aequor (Thousand Oaks, CA)
- …for our partners! Required Competencies and Skills: Key Responsibilities:1. Lead the review , drafting, and negotiation of contracts for members of the healthcare ... identifying potential process improvements and manage multiple assignments at one time. Review and either approve payments or triage errors to the appropriate staff… more
- Merck & Co. (Rahway, NJ)
- …Global Development Quality Operations - API, is responsible for independent review and approval of documentation to support Good Manufacturing Practice (GMP) ... our company's clinical supply programs. This person will also independently review and approve documentation accompanying the disposition of API materials (including… more
- Aequor (Swiftwater, MN)
- …(1-2) per week as required for any updated MSAT procedures b. MSAT document Periodic Review c. Review Record and System (R&S) periodic review report ... laboratory notebooks 4. Issuing and managing logbooks (print, bind and track) 5. Review and edit formatting for MSAT documents in Qualipso IV. Training Coordination… 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
- Merck & Co. (Durham, NC)
- …and our Company's Quality Management System focusing on batch record review , process/aseptic observations, critical site review , critical alarm management, ... site Tiers.Leads and Supports the Aseptic Observer Program (AOP) and Batch Record Review (BRR) workstreams for the SFQA Area.Makes decisions guided by policies and… 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …negotiations with clinical sites and vendors as well as budget review and forecasting Independently manage interactions with clinical monitors, data management, ... (at CRO or internally) to ensure robust plans for study level data review , including trend evaluation Provide input in internal/external study related audits, … more
