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The Associate Principal Scientist will work closely with individuals from PaCES, Clinical Research, Regulatory Affairs, Biostatistics, Outcomes Research, and Operations to ensure COA endpoint strategies are consistent with and correctly executed to support the product strategy.
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The individual will support teams on the development, validation, analysis, and interpretation of COA endpoints to support regulatory submissions, reimbursement evidence dossiers, payer interactions, and publications.
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Familiar with COA/PRO requirements for regulatory and reimbursement agencies Knowledgeable of methodological approaches and technical aspects (i.e. study design, data analysis and interpretation) of COA/PRO development, validation, electronic migration and interpretation into clinical trial and observational studies.
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The Sarbanes-Oxley (SOX) Control and Compliance Manager will lead the Company's internal controls program, perform regulatory compliance audits as needed, and support the Company's Environmental, Social and Governance (ESG) and Enterprise Risk Management (ERM) programs.
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Working closely with individuals from PaCES, Clinical Research, Regulatory Affairs, Biostatistics, Outcomes Research, and Operations, the Associate Principal Scientist ensures COA endpoint strategies are consistent with and correctly executed to support the product strategy.
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Public Safety Officers provide support to many areas of the University including Student Affairs, Facilities, Academic Affairs and Athletics. Knowledge of dispatch systems, radio communications, fire systems, CCTV, emergency procedures and switchboard communications is a plus.
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Collaborate with cross-functional teams, including R&D, manufacturing, quality assurance, and regulatory affairs, to ensure seamless integration of mechanical systems into final products.
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Demonstrated experience with the legal, regulatory and technical issues related to the ad tech industry and emerging technologies or privacy issues including iOT, AI and biometrics. Strong familiarity with the relevant legal and regulatory landscape in this area is required, as well as experience in providing counsel on U.S. and international data privacy and information security laws.
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Interact with Regional Market Access/Health Economics / Outcomes Research and Medical Affairs teams to coordinate and develop real world evidence generation in support of their access programs.
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It is the division’s leader in sterile product and process development, responsible for commercialization activities including process scale up, technology transfer to internal and external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations.
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The Director, US Sales and Sales Training will play a critical role supporting patients in the launch of a pipeline asset for a rare orphan respiratory disease in the US. In collaboration with Marketing, Healthcare Systems/Market Access (Commercial Affairs), Business Operations and Medical Affairs, the director ensures that our external contract sales organization is aligned with the overall brand strategy and launch objectives.
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Align and interface the JSC Product Strategy with other existing strategies: J&J corporate strategies, commercial strategies, R&D strategies, regulatory strategies, etc. Experience with developing and responding to quality content of regulatory filings, inspections, and preparedness activities.
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Coordinate COA/PRO related sections of evidence packages to be submitted to regulatory and reimbursement agencies. Facilitate alignment of the selection of an appropriate endpoint measure to satisfy both regulatory and reimbursement needs.
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About Safety Assessment Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance.
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Keep up to date with COA/PRO methodologies and guidelines (including those from regulatory authorities and reimbursement agencies) and communicate findings to cross-functional study teams as needed.
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regulatory affairs jobs Company: Kroll in Horsham, PA
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