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QualificationsTo be considered for this role, you’ll require a minimum of 5 years of professional experience in relevant field of healthcare products or related activities e.g.:Work in medical devices industry and/or in vitro diagnostic devices(preferred) or closely related industries (e.g., pharmaceutical industry) such as research and development, manufacturing, quality management, regulatory affairs.
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Outside of the RWE organization, the VP will work with leaders from other CMAO functions, Biostatistics & Data Management, Global Regulatory Affairs, Clinical Pharmacology / Pharmacometrics, HV&E , Legal/Compliance, Worldwide Medical and Safety, and others to achieve research and business objectives.
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Engage with regulatory agencies and industry stakeholders regarding regulatory and legislative affairs, including by providing feedback on proposed regulations. 2+ years' experience working in regulatory compliance or regulatory affairs for a consumer products, food, beverage, cosmetics or pharmaceutical company, or in a highly regulated industry.
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Extensive experience in statistical programming related to clinical trials analysis, reporting and regulatory submissions. Medical Affairs and HEOR. Ensure quality and timeliness of statistical analysis, reporting, and regulatory submission deliverables, addressing challenges with agility.
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Staying current with industry standards such as CDISC, and the regulatory requirements related to their use. 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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6+ years of progressive medical/scientific affairs experience within the pharmaceutical, biotech industry or at a consulting firm that supports the pharmaceutical or biotech industry; at least 3 years driving medical strategy.
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What you'll be doingThe Medical Science Liaison (MSL) functions as a field-based member of the Medical Affairs group in Medication Delivery, Baxter Healthcare Corporation. This role will collaborate with the internal Commercial and Medical Affairs teams in their therapeutic area of expertise to provide scientific information relevant to the launch of new products, and support key product strategies and publications.
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Managing the IT portfolio within Abbott’s IT organization (BTS/Corporate Strategy & Solutions) with leaders from Abbott Quality and Regulatory, Corporate Engineering (including Corporate Environmental Health and Safety), and Global Security, developing and maintaining comprehensive Application Lifecycle roadmaps, expertise on the applications, and prioritization of projects and demand.
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Develop, maintain, document, and lead continuous improvement in regulatory programs including but not limited to items such as Arc Flash, LOTO, Confined Space and Process Safety Management (PSM.
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The Animal Care Technician IV provides exemplary animal care and adheres to all department and AbbVie regulatory expectations. Applies basic computer skills to maintain regulatory compliance and training to include but not limited to, email, calendar, and computer based training modules.
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Identifies and resolves supply issues with all required stakeholders including Senior Management, Customers, Suppliers, QC, Regulatory, Finance, Sales, Clinical Pharmacy and Marketing. + Coordinates all activities with QA, PPT, PPM, Regulatory, Labeling, Product Security, CMOs and all other groups as required to ensure launch readiness for new products.
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Obtain Licenses: Become a FINRA (Financial Industry Regulatory Authority) Registered Representative by studying for and obtaining your SIE, Series 7 Top Off and Series 66 licenses, fully paid for and sponsored by Fidelity.
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You will report to the Director, Corporate Affairs Operations and will support teams within Corporate Affairs that includes Legal, Ethics and Compliance, Security Loss & Prevention and Environmental Health & Safety.
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The Childbirth Educator RN 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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Oversee regulatory compliance programs for disaster recovery efforts and ensure alignment with Corporate Risk Management strategy and goals especially the business continuity program office. The company issues the Discover card, America's cash rewards pioneer, and offers private student loans, personal loans, home equity loans, checking and savings accounts and certificates of deposit through its direct banking business.
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regulatory affairs jobs Title: regulatory affairs project Company: Gpac in Mettawa, IL
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