- Legend Biotech USA, Inc. (Raritan, NJ)
- …also provide oversight of technical, qualification, and validation activities including data or document review and approval as needed. This role will be ... within the siteReview and approve qualification/validation documentation (specifications, protocols, reports). Review and approve periodic review documentation for… more
- Eisai, Inc (Exton, PA)
- …processes and technologies, working with R&D and CMO personnel. Provide technical support and document review for phase III and PV at CMOs at the company's ... discretion.5. Lead and assist in troubleshooting upstream and downstream process, product, and equipment issues and deviations. Provide timely reporting, investigation, and resolution of manufacturing deviations, change control, and corrective and preventive… more
- Repligen (Hopkinton, IA)
- OverviewWe are seeking a Document Control/QA Associate I to join our growing Quality Department team in Hopkinton, MA for 1st shift operations (M-F) from 8 am EST - ... 4:30 pm EST.The Document Control/QA Associate I will report directly to the...manner while also serving as a resource for the review of quality documentation received from interdepartmental sources.ResponsibilitiesWorks with… more
- Merck & Co. (Rahway, NJ)
- …product. Make independent batch release or reject decisions.-- Conduct independent auditing, review , and approval of diverse and complex document types, as ... Global Development Quality Operations - API, is responsible for independent review and approval of documentation to support Good Manufacturing Practice (GMP)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …processes, and build appropriate mitigations. Drive interface with Integrated Data Review , Data Surveillance, targeted source document verification and targeted ... disciplines and cultures. Must have technical knowledge on integrated data review and derivation/interpretation of metrics that can dynamically interface with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategic and planning alignment across regions and functions and supports review of Local Country/Regional Medical Affairs activities when applicable. Provide ... evidence generating studies/projects. Manages all medical aspects such as study document development and drives execution for assigned projects in collaboration with… more
- Merck & Co. (North Wales, PA)
- …care systems that can enhance value and use of products.Implements programs to document the burden and cost of diseases, unmet medical need, patient reported ... and reimbursement dossier, which includes the development of the worldwide template document including global value dossier and input forms, design of data… more
- Merck & Co. (Rahway, NJ)
- …responsible for preparing responses to Internal Revenue Service Information Document Requests ("IDRs"), gathering information, preparing analyses to support ... gather necessary information.Key ResponsibilitiesPrepare detailed responses to IRS Information Document Requests (IDRs), ensuring all information is comprehensive and… more
- Merck & Co. (South San Francisco, CA)
- …development. PDMB aims to leverage Generative AI (GenAI) to enhance document authoring processes, thereby improving efficiency and compliance in regulatory ... the clarity, accuracy, and conciseness of regulatory documents to facilitate the review process. -Implement strategies to leverage GenAI for improving document … more
- Merck & Co. (Upper Gwynedd, PA)
- …and identification of potential risks.Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for assigned ... projects.Provide regulatory leadership as needed in product in-license/due diligence review and product transition to the Post-Approval Pharm CMC team.Manage… more
- Aequor (East Syracuse, NY)
- …GMP manufacturing. Duties / Responsibilities Develop, author, and peer review standard operating procedures, analytical methods, protocols, reports, and other ... and downstream manufacturing process development, characterization, and process improvements. Document and evaluate experimental results and perform data verification… more
- Aequor (Pearl River, LA)
- …various assays to monitor immune responses elicited by vaccine candidates and document laboratory work in electronic notebooks thoroughly. - Maintain cell lines, ... with general instructions, and work under moderate supervision with regular review . - Identify and report experimental problems, troubleshoot causative factors,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and dissemination across CSPV stakeholders for impact assessment. Participates in the review and management of monthly, quarterly, and ad hoc PVRI reports received ... Contribute to overseeing and setting standards for PV contract management. Review contributes to revision of DSI contracts under negotiation (eg development,… more
- Merck & Co. (Durham, NC)
- …to support investigations and develop appropriate CAPAs which lead to program improvements. Review and approve out of tolerance (OOT) records and ensure quality ... Maintenance, Deviation Management, Quality and other Site Business Partners.Initiate, Review or Approve changes in the Calibration system (ProCal).Manage approved… more
- Merck & Co. (Durham, NC)
- …to support investigations and develop appropriate CAPAs which lead to program improvements. Review and approve out of tolerance (OOT) records and ensure quality ... Maintenance, Deviation Management, Quality and other Site Business Partners.Initiate, Review or Approve changes in the Calibration system (ProCal).Manage approved… more
- Twist BioScience (South San Francisco, CA)
- …composition data and hazardinformation for accurate SDS generation. Manage the review , approval, and distribution of SDS to internal and external stakeholders. ... and collaborate with the Business Process Owner and EQMS users to develop and document configuration changes to meet business need Perform other duties & projects as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …processes globally. This role will be responsible for coordinating the authoring, review and approval of new or updated procedural documentation. In addition, this ... as a key regional point of contact for cross-functional process and procedural document related questions. The individual in this role will also be responsible for… more
- Aequor (Swiftwater, MN)
- …analysis of the sequences from different databases Design, analyze and document experiments, maintain proper records electronically and in lab notebooks Effectively ... with SOPs/SWIs and protocols Coordinate data capture and tracking information Write and review protocols and reports Serve as Molecular Biology SME to tech transfer… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(ESRs) and may serve as deputy regional medical lead in Global IIS Review Committee meetings. May serve as medical lead for select company-sponsored evidence ... generating studies/projects. Manages all medical aspects such as study document development and drives execution for assigned projects in collaboration with USMA… more
- Genmab (NJ)
- …with cross-functional trial teams to manage timelines, facilitate meetings, and lead review cycles.Provide expert peer review and editing support to elevate ... and ICH guidelines.Proficiency with writing tools such as MS Word, EndNote, document management systemsAbility to interpret and summarize tabular and graphical data… more
