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Reports to: Assistant Principal for Student Affairs Employment Category: Full-time, Non-exempt, 11-month Duties and Performance Responsibilities:General Administrative and Clerical Support Processes mail notification letters/disciplinary reports (with copies to appropriate internal parties) for parents of students on disciplinary probation or as requested by the Assistant Principal for Student Affairs.
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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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In this role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level and representing GSK with Precision Medicine/Digital Health partners and regulatory agencies.
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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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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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Must have on resumes: COA endpoint strategies, PROs, patient inputs, regulatory interaction, literature review, prepare questionnaires for patients in the trial, review trial protocols and analysis plans.
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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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Represents Global Regulatory Affairs (GR) within internal committees to provide regulatory advice and approval according to the committee charters (therapeutic area Document Review Committees, Product Development Team, Early Development Team, and Label Evaluation and Development Team.
$193,440 - $304,500 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Collaborates with Regulatory Affairs and the Office of Ethics and Compliance; is responsible for the review and approval of all promotional and presentation materials prior to use/distribution.
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Ten years of industry experience in functions engaged across the commercialization chain of drug development (business development, regulatory affairs, medical affairs, clinical development, clinical operations, process development, manufacturing operations, etc.
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Main Responsibilities: Manage the logistical aspects of Peer-to-Peer programs, content development and Key Opinion Leader (KOL) management in collaboration with medical affairs and medical education agency.
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Work with IT to improve technology used by Medical Affairs, such as utilization of Veeva technology. As the Medical Operations Project Director, you will play a pivotal role in supporting the Vice President of Global Operations and Medical Excellence in driving major initiatives to enhance our practices related to Global Medical Affairs.
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Rooming patients, taking medical histories, performing and recording vital signs, preparing exam room for procedures, explaining treatment procedures to patients, preparing patients for examination, facilitation of patient flow through the office, and assisting the Physician, Nurse Practitioner or Physician Assistant during examinations.
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The Vibrant Living Assistant in the Wellspring Village will play a key role in helping our residents enjoy each and every day. Other organizations sometimes call this role the Activities Assistant but we believe this role deserves the very special title of Vibrant Living Assistant.
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affairs job Title: regulatory affairs assistant Company: Abbott Laboratories in Norristown, PA
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