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In depth understanding of compliance and regulatory requirements for pharmaceutical Medical Affairs, R&D and Commercial work. Biotech / Pharmaceutical industry experience, with strong understanding of solid tumor drug development and medical affairs function.
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Our clients include DHS, DHA, DoS, USMC, US Army, HHS/Indian Health Service, Department of Interior, Bureau of Indian Affairs, Bureau of Indian Education, among many more. The Senior ServiceNow Engineer to support the US Army Corps of Engineers Revolutionary IT Services (USACE RITS) to manage and oversee the Configuration Management Database (CMDB) to inventory and troubleshoot existing information, as well as, mange integration and discovery processes such as generating patterns in discovery and creating or modifying new and existing patterns in Discovery.
ExpandApply NowActive JobUpdated 26 days ago - UpvoteDownvoteShare Job
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The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions.
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Cross-functional collaboration/interaction with Clinical Affairs, R&D, Regulatory, Quality, OEC, Legal, Global Marketing & Commercial teams. Supporting the Director of Global Scientific Affairs, in conjunction with the Sr. Manager and Project Manager in Global Scientific Affairs, with KOL management as it relates to investigator-sponsored studies (ISS) and/or collaborative research studies (CRS.
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Reporting to the Global Medical Affairs Strategy Lead (MASL) the Director will be responsible for the development and execution of the Global Medical Affairs strategic and tactical plans for the asset(s) for the primary indication as well as new indications to expand into as part of the asset life cycle management.
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A demonstrated track record of successful business experience in other related functional areas, such as Health Care Compliance (HCC), Medical/Scientific Affairs, Sales, Marketing, Legal, etc. Johnson & Johnson is currently seeking an Associate Director, Regulatory Advertising & Promotion to join our Health Care Compliance organization located in Titusville, NJ. At Johnson & Johnson,we believe health is everything.
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License to practice Speech Language Pathology issued by PA Bureau of Professional and Occupational Affairs is preferred. Will consider strong Clinical Fellowship Year (CFY) candidate for Long Term Substitute (LTS) positions in the Related Services program.
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The Rapid Cycle Analytics (RCA) Lead Data Scientist role sits within the Clinical Data Science and Evidence (CDSE) team, which is part of CMR. This role interfaces with internal stakeholders from Health Economics and Outcomes Research (HEOR), Real-World Evidence (RWE), Medical Affairs, Clinical Trials Operations, Market Access, and a few other teams to respond to quick turnaround data analytics requests.
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Ongoing demonstration of compliant collaboration, teaming and pull thru across stakeholders (Medical Affairs, Marketing, Sales Leadership and Market Access) to coordinate a consistent company approach to key customers.
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Deloitte Risk and Financial Advisory's Financial Services Industry (FSI) Risk, Data and Regulatory professionals help organizations identify the regulatory changes impacting their business and implement effective and efficient processes to manage regulatory, capital, liquidity and interest rate risks, respond to evolving regulatory environments and implement programs, measures, and tools to help clients with a specific focus on risk, data, and regulatory processes.
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Certificate of Clinical Competence in Speech-Language Pathology (CCC-SLP) is required. The Speech-Language Pathologist (SLP) will access needs, plan strategies and deliver evidence based supports to students with communicative disabilities across a variety of educational settings to include general and special education classrooms, specialized schools and community settings.
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Applicants must possess a current and valid license as a Speech Pathologist/Audiologist issued by the Audiology and Speech-Language Pathology Advisory Committee, Division of Consumer Affairs, Department of Law and Public Safety.
$72,014.33 - $949,416 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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As a visible RWE/D champion within the US organization, will interact with a wide number of NNI stakeholders across not only Clinical Data Science and Evidence (CDSE) but more broadly within Clinical, Medical and Regulatory, Market Access and Public Affairs, as well as collaborating where appropriate with therapeutically aligned global counterparts in Epidemiology, Data Science and Global Evidence and Pricing Access.
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Take on responsibility for oversight of vendors selected to manage ongoing RWE efforts, including Ph4 study management, and presentations and publications emanating from these effortsDrive ongoing collaboration with cross-functional teams (e.g., US medical affairs, HEOR, marketing, market access, global value and access teams, commercial) to prioritize projects toward achieving effective utilization of resources.
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Bachelors degree in Business Administration, Economics, International Affairs, or a related field. Bachelors degree in Business Administration, Economics, International Affairs, or a related field.
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affairs job Title: regulatory associate Company: Thermo Fisher Scientific in Pennington, NJ
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