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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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Represent RWV&E on cross-functional teams with business partners, such as Janssen Scientific Affairs, Medical Affairs, Marketing, Medical and commercial field organizations, Marketing, Strategic Customer Group, Global Commercial Strategy Organization, Commercial Insights & strategy, epidemiology, Government Affairs and Policy, New Business Development and other JJIM Operating Companies, as needed.
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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.
Up to $58.26 an hourExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Regional Medical Scientific Director (Medical Science Liaison) is a credentialed (i.e., PhD, PharmD, DNP, MD) Director Level Medical Affairs position and therapeutic and disease expert who engages in bidirectional exchange of scientific or medical information with Scientific Leaders (SLs.
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Public Safety Officers provide support to many areas of the University including Student Affairs, Facilities, Health Services, 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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Working knowledge of mortgage originations or mortgage servicing and/or risk-based auditing attained through 2-5 years of progressive work experience with a focus on financial risk and/or mortgage related regulatory requirements.
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Prepare State regulatory permit applications- Traffic Signal Permitting and Highway Occupancy Permitting. Project coordination with Transportation staff, clients, contractors, attorneys, PennDOT and residents.
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Specific experience interaction with HEOR/RWE/Med Affairs stakeholders at life sciences companies as either a vendor, partner, or collaborator. Managing design implementation and cross functional initiatives, and communicating effectively and confidently with life sciences clients, project team members, and senior management.
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Oversee the Tax Accounting functions, including regulatory reporting with government agencies (sales / use tax), represent Express on tax audits with outside government agencies (sales / use tax audits), facilitate communication with appropriate government agencies and company counsel related to tax matters, formulate tax projections for quarterly income tax payments, for preparation for city, states and federal tax returns with outside public accounting firm (Grant Thornton.
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Manage schedules and streamline work between all team members and agencies including internal creative development project briefings to collect information in order to drive the discovery process with creative, strategy, production, development, regulatory, QA teams to deliver projects in a timely manner.
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About Safety AssessmentCharles 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.
$25ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Ensures medical education strategies, marketing assets and tactical plans are developed and performed in close partnership with Global Commercial Strategy Organization, Sales, Sales Learning & Development, Medical Affairs, and key internal partners.
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Must have national accredited wound certification(CWS, CWCN, WCC, CWON, WOC, AWCC)or be committed to complete Advanced Wound Training and national accredited Wound Certification within 1 year of hire (For those hired with wound certification, completion of a fast-track hybrid program for regulatory wound care requirements will be provided) Clinical experience in a skilled nursing setting is strongly preferred.
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With a focus on maintaining high-quality standards and adhering to project timelines, the Foreman will lead a team of skilled professionals to ensure the successful completion of each project.
ExpandApply NowActive JobUpdated 6 days ago
regulatory affairs jobs Title: regulatory affairs project Company: Gpac in Horsham, PA
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