- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …protocol and amendments for small, uncomplicated clinical studies; Directs CRO medical monitor activities for Phase 2 studies; Regional sponsor medical monitor ... Collaborates with CSPV to ensure monitoring / reporting of AEs/SAEs, Reviews safety reports/data during study conduct, Provides and documents oversight of medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a culture of innovation across the whole organization, encouraging psychological safety and agile methodology to boost creative thinking and continuous improvement- ... Functional Units based on moving targets of business needs, keep track of monitor progress of the key deliverables and milestones, evaluating risks to delivery and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Additional medical writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.Lead the CRO and vendor selection process in collaboration ... with the CRO and the study team. Oversee the site qualification process. Monitor clinical trial performance and quality metrics and share with study team,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Additional medical writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.Lead the CRO and vendor selection process in collaboration ... with the CRO and the study team. Oversee the site qualification process. Monitor clinical trial performance and quality metrics and share with study team,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of protocol deviations- Discusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse ... are conducted by the Contract Research Organization (CRO) Medical Monitor (MM):- Provides oversight to the CRO MM for...well as management of adverse events based upon approved Safety Management Team (SMT) materials- Supports overall program … more
- Insmed Incorporated (Bridgewater, NJ)
- …Millennials™ lists.OverviewThe Director, Toxicology, is a key member of the nonclinical safety team, reporting to the Executive Director, Head of Toxicology and ... you will represent toxicology at cross-functional project teams, strategize nonclinical safety data package, oversee safety pharmacology and toxicology studies,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... and CI / CD infrastructure Troubleshoot technical issues that may arise Monitor , analysis, and comprehension of reporting data is essential Configure, operations,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …charter, etc), clinical data review excellence with a focus on patient safety and data integrity, site scientific engagement, and HA responsesInteractions with the ... achieving resultsLead (recruit, hire, coach, develop, motivate, manage and monitor performance) managers and/or professionals in department specific knowledge,… more
- Catalent (Philadelphia, PA)
- …They will have a deep understanding and values around patient and employee safety , will assist in the enforcement of GMPs and regulatory compliance through FDA ... Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. The Role: Responsible for… more
- Catalent (St. Petersburg, FL)
- …a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. The Quality Auditor will be ... supplier identified CAPA are completed in the required timelines Monitor and facilitate activities required to assure qualified status...a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …while innovating for future capabilities. We regulate accounting, uphold workplace safety , manage our supply chain and sampling, support technology, provide ... Leverage data, descriptive and predictive analytics, and data visualizations to monitor and improve business processes through actionable insights that drive… more
- Catalent (St. Petersburg, FL)
- …First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. Compliance Manager is responsible ... requirements include reading of written documents and use of computer monitor screen frequently. Professional with strong interpersonal skills. Strong verbal and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …This position has primary responsibility to manage Environmental, Health, and Safety (EHS) initiatives with a focus on environmental compliance and reporting. ... site compliance with local, state, and federal standards for occupational safety as well as environmental regulations.Relationships Reports to: EHS SupervisorNumber… more
- Catalent (Philadelphia, PA)
- …Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. The Role Responsible for ... include reading of written documents and use of computer monitor screen frequently. Why you should join Catalent: Defined...a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and… more
- Merck & Co. (Rahway, NJ)
- …that the material ordered is compliant with various site requirements (eg, environment and safety ) and other regulations as needed, and that the entire team is kept ... implement analytical methods that can interface directly with the process stream to monitor and control the process. As time permits, the Associate Specialist will… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and External Vendors for the data services they ... of data acquisition, processing, and reporting of external data across programs. Monitor vendor performance by collection and review of metrics and key performance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... user needs Ensure successful implementation and adoption of the product Monitor product performance and make data-driven decisions to continuously improve the… more
- Novo Nordisk Inc. (Durham, NC)
- …cGMPs & SOPs. Relationships Shift Manager. Essential Functions Setup, operate, monitor & control equipment, systems & processes Clean & sanitize manufacturing, ... level) Record/review production data in BPR & associated forms Follow all safety & environmental requirements in the performance of duties Other accountabilities, as… more
- Catalent (St. Petersburg, FL)
- …vision requirements include reading of written documents and use of computer monitor screen frequently. Why You Should Join Catalent152 hours of PTOCatalent offers ... a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and...of our recruitment and on-boarding processes to maintain everyone's safety . The Human Resources teams will communicate all necessary… more
- Eco Recovery Solutions (Shrewsbury, MA)
- …Responsibilities Quickly become knowledgeable of the ERS systems and processes Monitor and maintain on-site equipment and related systems, including conveyor ... operation Maintain and follow all Company environmental compliance, health and safety requirements, policies, procedures and rules Perform preventive and repair… more
