- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Associate Director (AD) is responsible for overseeing all activities related to Medical Review for their assigned Therapeutic Area (TA). The AD is accountable for ... AD partners with senior colleagues in developing and implementing improvements in medical review processes and is also an integral member of the Medical Affairs… more
- Merck & Co. (North Wales, PA)
- …not limited to) the implementation of primary data collection, chart review /survey, database studies, health economic model development and adaptations, dossiers, ... activities including study execution through close-out of primary data collection, chart review , and database studies in addition to other activity types. Manages a… more
- Merck & Co. (Durham, NC)
- …direct in-line Quality support for all compliance and environmental monitoring matters, review of atypical events including accessing product impact for EM events, ... providing Quality oversight to alarm events during processing, review and approval of incursions, review and...during processing, review and approval of incursions, review and approval of batch record documentation, and Reports.Requires… 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)
- …healthcare professionals- Oversee the timely execution of the development, review and approval process incorporating input/recommendations from other reviewers (eg, ... and discussing with other functions as needed- Ensure detailed peer review of medical information documents and provide appropriate and effective… more
- Catalent (Philadelphia, PA)
- …Quality Assurance Document Control individual is responsible in preparing customer files, review and approve batch records, and release batch records and finished ... to our customer's quality assurance groups for batch record review and release. The Quality Assurance Document Control manages...of every patient, consumer, and Catalent employee. The Role Review and approve all batch records prior to production… 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 (PA)
- …change orders, and SOWs.Participate in New Product Evaluation (NPE) and deal review meetings and support the site selection process.Hold and/or participate in ... technical review meetings with prospective clients and current partners to...collect relevant information required to draft comprehensive proposals and review drafted proposals throughout the lifecycle of an opportunity.Lead… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …that audit targets for tactical and strategic GVP audits are in place. Review risk assessment documents stemming from audit outcome to increase compliance within ... improvement to stakeholders via the QMS scheme (ie, Quality Management Review , Quality Review Board) across the global CSPV organization leaders and relevant… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …documents (writing of ICF, DM charter, response assessment charter, etc), clinical data review excellence with a focus on patient safety and data integrity, site ... also ensure the writing of high-quality clinical trial protocols, review of clinical data and Clinical Study Reports (CSRs)/outputs...or delegate at key R&D forums/groups such as Development Review Forum (DRF), Protocol Review Group (PRG)… 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)
- …Oversight of annual reports Participate in project team meetings as assigned Review data from contributing departments (including NNAS) and provide comments to ... assure accurate and complete documents for inclusion in these applications Review of regulatory strategy documents; eg, provides supervisor with input on regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …specifications as per CDISC SDTMIG.Perform SAS programming to provide complex data review listings and reports to support Data Management and clinical teams.Develop, ... implement and maintain SAS programming standards and performs quality checks. Review annotated case report forms and database structures.Develop reports & graphs in… more
- Merck & Co. (Millsboro, DE)
- …with Guidance from the QC Manager, ensures product/process quality through the review of GMP documentation and performs activities to ensure the efficient testing ... closely with various departments in receipt, distribution, scheduling of QC tests, and review and release of antigen and seed batches. The QC associate specialist… more
- Catalent (San Diego, CA)
- …Practices) regulations.Liaison between Manufacturing and QA for executed Batch Record Review and flow of documents.Liaison between QA and client and effectively ... communicates with clients in regards to Executed Batch Records (EBR) and review status.Tracks status of Executed Batch Records and maintains established deadlines… more
- Aequor (Devers, TX)
- …manufacturing compliance with applicable procedures and batch records. Perform real time review of manufacturing batch records. Review manufacturing shop floor ... cGMP requirements. Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with… 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 ... and synthesize inputs.Maintain a taxonomy playbook complete with structured business review templates to facilitate tradeoffs / reprioritization discussions with BU… more
- BioAgilytix (Durham, NC)
- …ResponsibilitiesPerform Quality Control (QC) technical, scientific, and compliance review of data and documentation generated by the Bioanalytical ... OOS and OOT associated with Bioanalytical Operations data as applicableIssue QC review observations and work closely with the scientific staff to ensure data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CCDS; Ensures implementation of CCDS/labeling agreements with licensing partners.Conduct Label Review Committee Meetings: Prepares documents for review by ... for US, EU and Company Core documents as well as for the review of country labeling deviations.Ensure Compliance with Labeling Regulations and Guidance: Researches… more
- Merck & Co. (North Wales, PA)
- …and regulatory submissions including assisting in preparing submissions, protocol review , and conducting research on regulatory guidance's or competitive ... also assist or take the lead in tracking, authoring, shepherding and/or review of responses to Agency requests.Implements strategy to develop agency background… more
