- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …safety, including project-specific training and coaching of team members and review of team output cross-functionally.- Effectively represent the CSPV on the ... providing the safety leadership and serving as the primary point of contact.- Review and analyze data from clinical trials, post-marketing and other relevant sources… 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
- Merck & Co. (North Wales, PA)
- …of escalated complex global HCP inquiries, and insight generation/analysis), Medical Review of US and HQ-created global Promotional Materials and Scientific Content, ... international congresses to verbally answer unsolicited inquiries from HCPs.Scientific/Medical Review of US and Global Promotional and Non-Promotional Materials:… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …case processing activities, which include the receipt, documentation, triage, case review , and quality assessment of all inbound safety information, including ... initiatives/activities, social/digital media monitoring services, and Registries incl. contract review and negotiation, with management of SDEA requirements, and… 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 (San Diego, CA)
- …Title: Quality Assurance Associate, Analytical City: San Diego State : CA JOB DESCRIPTION: Review of analytical release and stability data, involving review of ... (PXRD), Thermogravimetric analyzer (TGA) and Differential Scanning Calorimeter (DSC). Review Hardness testing and Friability of tablets, Content Uniformity and… 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
- Merck & Co. (Durham, NC)
- …functions of the Specialist, Quality Assurance is to assist in the review of batch records, media batch release, investigations, support of operational excellence ... implement quality system initiatives and continuous improvements.-Core responsibilities: Data review for batch release and other activities.Supports the deviation… 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)
- …to timelines, budgets, project, and quality plans, and relevant ICH/GCP Guidelines Review protocols to ensure designs are implementable to efficiently achieve the ... Access Program (MAP)/(EAP)Support the oversight of the overall global oncology review process of PhIV company sponsored studies per the Standard Operating… more
- Merck & Co. (Rahway, NJ)
- …and/or subsidiaries for all applications and submissions.Responsible for regulatory review and final approval of all submissions and associated ... coordinates cross-functional regulatory support for development programs and marketed products. Review and provide final approval of local registration study… more
- Eisai, Inc (Nutley, NJ)
- …and execute Phase IV clinical development programs for assigned products.Design and review IIS strategies and review proposals in conjunction with company ... policies, as well as providing critical inputs to review of CME grants.She/He will independently provide subject matter expertise and overarching engagement strategy… more
- Merck & Co. (North Wales, PA)
- …related to medical devices or the device constituent of a combination product. Review and approve Design Control and Device Risk Management documentation for ... controls and supplier quality.Work with external partners to develop products. Review and approve verification/validation test protocols and reports to ensure… more
- Lundbeck (Chicago, IL)
- …to measure and evaluate the effectiveness of training and provides metrics for management review Acts as a point of contact for sales and marketing teams regarding ... on various advisory committees Oversees Veeva Vault Submissions for internal review process with Medical and Legal teams Manages relationships with external… 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
- Aequor (Thousand Oaks, CA)
- …inventory accounting for certain manufacturing sites. Will be accountable to manage and review the work of an outsourced provider that supports this team. Perform ... and review sophisticated journal entries, general ledger account analysis, and...reconciliation for both SAP and consolidation tools. Prepare and review audit schedules and answer questions from internal and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …strategic and planning alignment across regions and functions and supports review of Local Country/Regional Medical Affairs activities when applicable. Provide ... Clinical Operations and other cross-functional and regional stakeholders.Provides support in review of investigator-initiated studies (IIS) and may serve as deputy… more
- Merck & Co. (North Wales, PA)
- …success together with risk mitigation measures.Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing ... business processes and systems.Collaborate with partner groups in critical review of submissions to ensure compliance, scientific excellence, accuracy and… 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
