- Merck & Co. (North Wales, PA)
- …to ensure a thorough understanding of the science behind the medicine and review further unmet medical needs to support collaboration to further differentiate our ... portfolio.The Medical Consult and Review Physician provides clinical expertise and advice to internal stakeholders and is a member of several cross-functional teams,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and maintenance of the CCDS, US and EU labeling, and manages the review of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance with ... group and across the cross-functional and cross- regional representatives on the labeling review teams as well as with business partners to achieve high quality and… more
- Insmed Incorporated (San Diego, CA)
- …teams, contract research organizations (CROs), and external vendors to prepare, review and finalize clinical study documents and plansContribute to scientific and ... design planning through final reporting of results Provide scientific input and review of clinical study data, support in assessing medical monitoring reports, study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and maintenance of the CCDS, US and EU labeling, and manages the review of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance with ... group and across the cross-functional and cross- regional representatives on the labeling review teams as well as with business partners to achieve high quality 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 ... system case evaluation, Safety system case evaluation, retroactive call listening, call transcription review , email case review , postal mail case review ,… more
- Merck & Co. (Rahway, NJ)
- …to identify inventory at risk and present results to Senior Management. Perform a review of our Company's top key products in order to understand inventory trends. ... from Supply Chain Management to identify matters affecting inventory levels Review inventory footnote and work with consolidation/accounting standards to ensure… more
- Merck & Co. (Rahway, NJ)
- …certificates of correction) and prepare applications and other documents for filing- Review notice of allowance and file history; prepare documents for internal ... review , including the preparation of allowed claims and payment...orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. -… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …functions as identified Regularly supports budget manager in preparation for RE/AB review cycles, reporting, and preparation for leadership budget review ... Project and Operations Oversight Build budget tracker/dashboard using flash report for quarterly review with POLT/POLT -1 for monthly review and quarterly POLT… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Regulatory Intelligence (PVRI) and dissemination across CSPV stakeholders. Participates in the review and management of monthly, quarterly, and ad hoc PVRI reports ... PV relevant contracts. Oversee and set standards for PV contract management. Review contribute to revision of DSI contracts (eg development, license, distribution… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Under the direction of the labeling leadership, the manager will develop, review and revise labeling for FDA submission, create and modify Structured Product ... listing, track and archive affiliate labeling for global products and review proposed labeling from affiliates. Responsibilities Provide Regulatory support in the… more
- Daiichi Sankyo, Inc. (Bernards, 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with the appropriate stakeholders to ensure timely remediation.SOP Authorship and Review Maintain a close working relationship with Quality Assurance and participate ... Ensure relevant stakeholders are involved at the appropriate time in the drafting and review of SOPs. Facilitate cross functional alignment prior to and during SOP … 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 ... learnings identified. May be assigned to support GSOP activities including the review as appropriate. Other duties may be assigned.Cross-functional and Global Team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Responsibilities:- Protocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, ... for complex studies including study design, protocol development, CRF review , SAP development, analysis files development, statistical analysis accuracy validation,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …the Controller including general ledger reconciliation and monthly closing. Will review and approve payroll reports, bi-weekly payroll submissions, reconciliation of ... and benefits to the General Ledger, accounts payable vouchers, review of cash disbursements, various review of...will provide reasonable accommodation to any employee with a disability who requires an accommodation to perform the essential… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Negotiations and Industry trends. This requires labeling verification to include the review across the product family of physician and patient leaflets, carton and ... to ensure labeling compliance and accomplish company goals. Key Responsibilities Review and provide regulatory guidance on commercial labeling materials to ensure… more
- Novo Nordisk Inc. (Virginia, WA)
- …measures, market updates and insights to ensure teams remain up-to-date Analyze, review and provide monthly report on Educator activities for direct reports to ... targets Responsible for ensuring and tracking compliance with regulatory/legal mandates Review and audit direct reports' expense reports. Exercise prudent control of… more
- Merck & Co. (Durham, NC)
- …these site-wide management programs by defining requirements established via in-depth review of existing systems and aligned with strategic direction defined by ... of compliance (metrics), obstacles and challenges to site management, including a review of topics of responsibility at the Site Quality Council Meeting per… more
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