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Knowledge and experience in clinical and CMC regulatory affairs for pre-licensed and clinical RA for licensed biologic product or vaccine. As a Director, Regulatory Affairs, Vaccines you will e nsure the development and execution of the appropriate Regulatory strategy(ies) for assigned US asset(s), across all stages of the product life cycle and consistent with the Vaccines Development Strategy/Integrated Asset Plan (IAP.
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This position interfaces with key divisional and cross-functional teams, including Expert Committee Management (ECM), Legal, Global External Affairs, QA, IT, HR, Equity, Travel, Finance, and USP’s Expert Volunteers community, to optimize efficiency within Volunteer Engagement & Compendial Operations while maintaining compliance with USP policies.
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Assist in the preparation and review of bioanalytical data and reports suitable for regulatory submission. Background in molecular biology techniques such as cloning, site-directed mutagenesis, DNA and RNA isolation and purification, sequencing, RT-PCR, and qPCR.
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Basic Qualifications:Bachelor's DegreeExperience of all phases of the drug development process in Regulatory Affairs preferredKnowledge of clinical trial and licensing requirements in all major countries (EU,US, JP, China) and ideally knowledge of other key Agency processes globally.
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Under the supervision of a senior staff from the Data Management group, the incumbent will work closely with colleagues from Biostatistics, Statistical Programming, Clinical Development, Clinical Operations, Regulatory Affairs and Medical Affairs.
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The Scientist will provide subject-matter expertise in a range of translational research strategies, immunoassay techniques, assay development, and fit-for-purpose Regulatory approach. Experience and aptitude for development and implementation of translational or biomarker strategies, preparation of scientific publications, presentations, and regulatory documents is a plus.
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Lead and shape future clinical development strategy and clinical development plans, working closely with Development and Discovery Program Leads and counterparts in Regulatory, Clinical Development, Clinical Operations, Biostatistics, Clinical Pharmacology, Medical Affairs, Commercial, Non-clinical and Discovery Research for assigned studies.
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They serve as general counsel for the following County agencies: Montgomery Fire and Rescue Services, Office of Human Resources, Office of Labor Relations, Department of Correction and Rehabilitation, and the Police Department and its Internal Affairs Division.
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Collaborate with Manufacturing, Quality Control, and Quality Assurance in supporting internal and external cGMP compliant operations, regulatory audit preparedness. Experience with regulatory audits of cGMP manufacturing sites.
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The Senior National Sales Manager will work closely with all necessary functions at the local levels to ensure that the category's products establish competitive positions, specifically, Vice President Sales, Marketing, Medical & Scientific Affairs, Operations, Market Access & Channels, Commercial Excellence.
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Maintain and update files of all applicable regulatory documentation for Institutional Review Board (IRB). Instruct data entry and clinical staff in procedures relative to data management, protocol instructions, Standard Operating Procedures and regulatory processes and considerations.
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Keeps abreast of and ensures compliance with regulatory practices (e.g. FDA, EMA, and ICH guidance and recommendations) and industry data standards (e.g. CDISC). Represents Emmes at Sponsor, Regulatory, Investigator, or Safety Review meetings (e.g., Data and Safety Monitoring Board Meetings.
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Write, edit, and review analytical sections of CMC regulatory filings. Excellent record keeping abilities to adequately record, analyze, and document analytical data generated in support of regulatory requirements.
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You will support data quality monitoring using official ICD-10 documentation guidelines and regulatory requirements in the Kaiser Permanente Health Connect electronic medical record system. Reporting to a Medical Coding Team Manager , the Medical Coding Reviewer I will conduct data quality monitoring of physician documentation to validate code assignment in compliance with the official coding guidelines as supported by clinical documentation in the health record.
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Typically minimum of ten years relevant engineering, project management, and/or licensing/regulatory affairs experience. Experience leading licensing/regulatory affairs teams in achieving regulatory outcomes (i.e., safety evaluations, design approval/certification, license issuance) including experience managing interactions with expert advisory committees or equivalents.
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regulatory affairs jobs Title: regulatory affairs project manager Company: Aerotek in Gaithersburg, MD
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