- Aequor (Seattle, WA)
- …of working within quality document systems and managing the on-time document review cycles for a cross functional team. Key Responsibilities The ... data verification processes to ensure accuracy and integrity. Lead quality system document review and routing. Follow up with reviewers and approvers in Client … more
- Merck & Co. (North Wales, PA)
- …processes for informed consent, compliance, Supplier training, site contract and budget review /approval, protocol document review (including DRC), study ... not limited to) the implementation of primary data collection, chart review /survey, database studies, health economic model development and adaptations, dossiers,… more
- Merck & Co. (North Wales, PA)
- … document flow to/from internal and external service providers, joint venture document review and clearance and independent manuscript review .Tracking and ... with congress plan activities including development/maintenance of presentation trackers, document trafficking, author travel request management, archival of final… more
- Merck & Co. (Durham, NC)
- …to the pharmaceutical industryExperienced in the methods and approaches of conducting document review & quality audits PHYSICAL REQUIREMENTS: Ability to sit, ... direct in-line Quality support for all compliance and environmental monitoring matters, review of atypical events including accessing product impact for EM events,… more
- Merck & Co. (Rahway, NJ)
- …regulatory advice and approval according to the committee charters. (Therapeutic area document review committees (DRC), Global Regulatory Team (GRT) Product ... and/or subsidiaries for all applications and submissions.Responsible for regulatory review and final approval of all submissions and associated… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …operational input into study protocol profiles, final protocols and amendments.Lead document review & coordination for the protocol and amendments. ... bring deviations to the Operational program Lead and study team leader. Review and approve Vendor invoices, including investigator grants and pass through… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …operational input into study protocol profiles, final protocols and amendmentsLead document review and coordination for the protocol and amendments. ... bring deviations to the Operational program Lead and study team leader. Review and approve Vendor invoices, including investigator grants and pass through… more
- Aequor (Thousand Oaks, CA)
- …will be required to administer the processing of documents via the established Document Processing Review process. May require communication through a variety of ... Office expertise; previous technical writing experience; regulated environment experience; document version control experience; excellent communication/writing skills Responsibilities Own… more
- Insmed Incorporated (Bridgewater, NJ)
- …such that all components are provided and presented in the correct format.Manage document review and approval as needed.Assists with other projects to support ... submissions. In addition, this individual will be responsible for general document management activities relating to the archiving of submission and submission… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …sets that meet functional / non-functional business requirements Excellent technical writing, document organization, technical document review and analytical ... thinking skills are required Demonstrated problem solver with an ability to provide technical solutions to a wide range of complex problems Excellent interpersonal, negotiation, written and oral communication skills Expert knowledge of systems analysis and… more
- Catalent (Philadelphia, PA)
- Quality Assurance Document Control Supervisor Position Summary Catalent Pharma Solutions in Philadelphia, PA is hiring a Quality Assurance Document Control ... tasks and making adjustments when necessary to meet commitments.Publish daily review /release schedule and completed work report for previous day; Takes initiative… more
- Catalent (Philadelphia, PA)
- …the primary liaison to our customer's quality assurance groups for batch record review and release. The Quality Assurance Document Control manages the ... Quality Assurance Document Control Position Summary Catalent Pharma Solutions in... Control individual is responsible in preparing customer files, review and approve batch records, and release batch records… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will also provide oversight of technical operations activities including data or document review , risk assessments, CAPAs, and continuous improvement activities. ... They will be a subject matter expert for the manufacturing process and provide front line support to address and resolve manufacturing issues.Key Responsibilities Provide Quality Oversight and technical expertise to the Technical Operations and Manufacturing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …post trial information on required public forums (eg.clinicaltrials.gov).- Under supervision, review and document CRO-generated reports, such as site monitoring ... with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities- Reconcile the TMF document trackers generated by the CRO with the document archive.… 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 ... stakeholders to gather feedback, incorporate their input and manage expectations. Document the new process, including standard operating procedures, work… more
- Eisai, Inc (NJ)
- …will have proven ability to effectively manage the outsourcing of document preparation when necessary and the associated service providers. Essential Functions ... Clin Ops. etc. to ensure alignment on program objectives, facilitate document reviews, proactively resolve any issues etc.With minimal supervision, preparing and/or… more
- Novo Nordisk Inc. (Minneapolis, MN)
- …least 24 hours of coaching per month to Regional Account Managers and document accordingly Area accounts - market access strategies: Anticipate problems that may ... of resources to ensure attainment of strategic account and NNI profitability goals Review and audit expense reports Market access planning: Assist in providing input… more
- Merck & Co. (North Wales, PA)
- …Standards, Trial Design, Trial Data Collections, Trial Data Integrations, and Trial Data Review solutions are the mechanism used to ensure the right data is ... and communication to users.You will apply a structured approach to discover, document , and manage business process and stakeholder needs. You will also gather… more
- Catalent (Manassas, VA)
- …the plant infrastructure. Equipment verification including metal detector, x-ray, scales, etc. Review and verify paperwork of operators to ensure they are meeting ... complete appropriate details; Report any housekeeping issues that need attention. Document all areas of non-compliance and ensure corrective actions are completed.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …needed.Responsibilities- Contract Coordination: Collate exhibits to create contract draft, Review contract documents for completeness and accuracy; Ensure compliant ... Update CLM system/trackers throughout the process.- Conduct simple negotiations review contractual amendments details against original contract. Ensure internal… more
