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Qualifications: At minimum, a Bachelor’s degree in Chemistry, Biology or related science with a strong background in DMPK and BA including knowledge of the FDA GLPs. + years of Regulatory drug development experience Experience with CTD documents and nonclinical study reports for submission to global regulatory agencies.
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Global Supply toward 'Industry 4.0' capability through Big Data, Process Analytical Technology, Advanced Process Control, Artificial Intelligence and Robotics. s Global Technology & Engineering will help to drive.
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Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests, digital health and other devices to enhance the value of our pharmaceutical products across therapeutic areas.
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Responsible for the global regulatory evaluation of CMC change controls with supervision. Participate in global regulatory interactions with health authorities, with supervision. Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions.
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STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. The Maintenance Manager will establish and maintain the department's CMMS (computerized maintenance management system) and pursue training to become the Radiation Safety Officer for the facility.
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Our spectrum of Global Information Reporting services range from FATCA, CRS, chapter 3 and 61 tax compliance globally, tax form validation services, Qualified Intermediary and Withholding Partnerships regimes, technology development in these areas, consulting services, controversy, risk management and audit readiness for these regimes.
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Claims QA – Liaise with the Global Claims QA Lead to ensure alignment of TPA audit plans on an annual basis and support the facilitation of each audit. Quarterly Relationship with our ‘strategic’ TPAs along with the Global Claims Vendor Lead. Claims QA - Liaise with Global Claims QA Lead to agree annual audit regime for TPAs. Risk/ Compliance – As it relates to Sanctions, Financial crime and Conduct risk.
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Partners with internal colleagues (Brand Teams, Hub management, Global/Regional TA Leads, Area/Regional medical) to ensure creation of relevant core content to meet customer needs. + Identify global medical information insights based on Medical Information inquiries and partner with cross-functional colleagues to identify scientific gaps and strategic solutions.
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Our BusinessWe are a global leader in environmental consulting - made stronger with the recent acquisition of Wood’s Environment & Infrastructure business and Golder - with world-class expertise in environmental, social and governance (ESG), climate resiliency & sustainability (CRS), and earth sciences.
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This is a global role that will report to the Head of Global Medical Excellence Learning & Development within the Global Medical Strategy and Operations team. Key responsibilitiesLeads the development of the learning strategy, curriculum development, and content creation for onboarding and ongoing training of Medical Affairs scientific teams across within the virology therapeutic areas, with a focus on HIV (Treatment and Prevention) and Liver Disease (HBV, HCV, HDV, PBC.
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The entities of Citrin Cooperman & Company, LLP and Citrin Cooperman Advisors LLC are independent member firms of the Moore North America, Inc. (MNA) Association, which is itself a regional member of Moore Global Network Limited (MGNL.
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OPEN Health is a flexible global organization that solves complex healthcare challenges across HEOR and market access, medical communications and creative omnichannel campaigns. Associate Project Manager Remote role; Ideal candidate should be based in EST time zone.
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In this role, a typical day might include:The Regulatory Intelligence Manager performs proactive global monitoring and surveillance of changes in the regulatory landscape focused on the drug development lifecycle, i.e., preclinical through commercialization, as well as disseminate relevant regulatory intelligence information to Regeneron stakeholders.
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Define resourcing and budget needs to deliver the aligned E2E Master Data Plan. Partner with global Data Management Transformation & Governance teams to bring required capabilities and resources to deliver the E2E Master Data Plan for the Project (e.g. Certified Master Data Lake, SAP PLM, SAP MDG, Data Quality capabilities, etc.
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Innova Solutions is immediately hiring a Trial Supplies ManagerJob Title: Trial Supplies ManagerPosition type: Full-time ContractDuration: 06 MonthsLocation: Remote, USAPay range: $74 -$ 78 Per HourAs a Trial Supplies Manager, you will:This position is responsible for the supply planning and inventory management of clinical supplies required to support global clinical research and development studies during phases 1-4.
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