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This new position will work closely with Global and Regional Market Access, HEOR, Marketing, Medical & Clinical Affairs, Research & Development, and Government Affairs colleagues to help ensure patients gain appropriate access to Abbott’s life changing point of care, rapid diagnostics.
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Advanced knowledge and understanding in the core areas of government affairs and policy (Stakeholder and Alliance Development, Government Relations, Political/Campaign experience, Access and Reimbursement Public Policy and Economic Analysis) to maximize colleague contributions.
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5-7 years of pharmaceutical experience a minimum of 3 years advertising and promotion regulatory experience preferred but may consider medical/scientific affairs with a of minimum 5 years direct advertising and promotion review experience.
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The position will report directly to the Laboratory Director and work alongside technical staff specialized in fields of analytical, toxicology, and regulatory affairs as well as other labs and functions.
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Maintain and lead continuous improvement in regulatory programs including Arc Flash, LOTO, Confined Space and Process Safety Management (PSM). POSITION SUMMARY The Maintenance Manager reports to the Operations Manager and is based out of our Seabrook, New Jersey location.
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Consulting with Global Regulatory Affairs to understand complex Regulatory Information Management (RIM) business needs to determine how they will affect applications and systems. The position has the responsibility for partnering with Global Regulatory Affairs and other R&D functions, learning their processes, and finding opportunities whereby technology can help drive efficiencies.
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The Interventional Radiologic Technologist reflects the mission, vision, and values of NM, adheres to the organization's Code of Ethics and Corporate Compliance Program, and complies with all relevant policies, procedures, guidelines and all other regulatory and accreditation standards.
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Providing feedback on CRF design and SDTM datasets to ensure data are collected and represented in a manner that support regulatory requirements to comply with CDISC standards (CDASH, SDTM and ADaM) and AbbVie standard extensions to CDISC.
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Team with Store Manager, Designer and selling team to promote In-Home Design Sales program and drive store sales. Adhere to operational procedures and guidelines outlined by the Company and other duties assigned by the Store Manager.
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Partner with internal stakeholders to ensure appropriate customer facing dissemination of HEOR materials per regulatory guidance and internal SOPs. Provide strategic input into clinical trial designs (e.g., patient populations, comparators, endpoints) and analysis to enable successful negotiations, reimbursement, and appropriate patient access with global payer and regulatory decision makers.
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The successful candidate:Hours: Mon - Fri 40hrs per weekThe Quality, Regulatory and Compliance (QRC) Sr, Specialist plans, coordinates, and leads all areas of the Hematopoietic Stem Cell Transplantation and Cellular Therapy quality, regulatory, accreditation, and compliance related activities including critical third-party manufacturing services involved in the procurement, processing, testing, labeling, storage, distribution, release, and administration of cellular therapy products.
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Coordinates TPM related programs such as product transfers, continuous improvement initiatives, material changes, validation of new manufacturing process, etc., providing oversight and guidance to Supply Chain, Quality, and Regulatory functions.
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As an integral core member of cross functional teams the Senior Scientific Director provides strategic medical input into core brand (product) strategies, and to support medical affairs, marketing activities (promotional material generation and product launches) and market access.
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The next Vice President for Finance and Institutional Planning will oversee all business affairs, serve as Treasurer of the College, manage facilities, accounting, budget, business services, human resources, information technology and student financial services.
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The Village at Victory Lakes is hiring for a Resident Care Manager for our Skilled Nursing Community. The Resident Care Manager / RCM is responsible to ensure the highest quality of care is always maintained.
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regulatory affairs jobs Title: affairs manager Company: Gpac in North Chicago, IL
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