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Stays informed of industry trends, technological advancements, and regulatory changes related to order fulfillment and pharmacy operations. Responsible for the efficient workflow of order processing to include product picking, labeling, verification and shipping of finished goods on time-in full.
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In certain situations, may serve as chair of Core Medical Team, at the discretion of the Executive Director Represent NNI Medical Affairs on Global Core Medical Team (CMT) Collaborate with HEOR to provide clinical input on HEOR projects and authorship on abstracts, posters, and manuscripts, when requested Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required.
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Lead and oversee scientific, strategic, planning and execution of biologics formulation development, drug product development and validation including process selection and scale-up, packaging and labeling development, technology transfer, and drug product characterization.
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Execute labeling, packaging, and shipping of domestic and international shipments of internally manufactured radiopharmaceutical drug product programs. Domestic and international shipping experience, including knowledge of customs clearance and regulatory requirements for RAM shipments for ex-US countries.
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Education Qualifications (from an accredited college or university) - Bachelor's Degree in Business, Science, Library Science, Data Management or related field is required required Experience Qualifications - 1 or More Years 2-3 years in documentation management; knowledge of cGMP’s required - Knowledge of labeling regulations preferred - Knowledge of print production preferred - APICS certification preferred Travel Ability to travel up to 5.
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Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. Primary Talent Partners has a 12 month contract opening for a Regulatory Affairs Specialist (MDR) with a Medical Device client of ours.
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We’re seeking a Regulatory Affairs - Specialist Global Labeling Lead Medical Devices to work at a premier medical device company in Rochester, NY. With us, it’s all about finding the job that’s just right.
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This position will closely interface with Clinical Operations, Quality, CMC, Regulatory, CDMOs and CROs to ensure clinical/investigational material is available as required to achieve clinical trial strategy and program timelines.
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Communicate effectively and transparently with functional heads within pharmaceutical development and other company stakeholders (Quality, Toxicology/DMPK, Clinical/Regulatory, Operations, Project, etc.
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Responsible for receiving, sampling, labeling, processing and placement of hazardous and non-hazardous materials to include bulking, consolidation, pumping, and processing in accordance with regulatory requirements to ensure that the end product meets the appropriate specifications for disposal.
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Other tasks that may be required during periods of time when the mobile phlebotomist is not traveling include performance of quality assurance tasks, result faxing, supply ordering, and receipt of surgical samples, tissues, fluids from other departments, 24-hour urine management, and ensuring accuracy of labeling and patient ID prior to processing for transport to lab.
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You will provide strategic input and operational leadership and oversight of regulatory labeling activities for all products in our oncology and cell therapy therapeutic areas. Oversees and guides the preparation and maintenance of regulatory labeling for multiple products across the oncology and cell therapy therapeutic areas.
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Work collaboratively with Regulatory Affairs and Research and Development regarding Product Development (Design) Controls, Design Assurance, and Labeling Control. Strong expertise in domestic and international regulatory compliance requirements (e.g. FDA QSR, ISO/EN standards, and MDSAP.
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The Senior Regulatory Affairs Specialist provides regulatory guidance to cross-functional teams; develops global regulatory strategies; advises on labeling and marketing materials for regulatory compliance; and evaluates product changes for impact on regulatory filings worldwide.
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Regulatory Affairs representative for theCT/AMI Systems and assists with regulatory issues related to such items as labeling and marketing ideas, claim development and prepares documents required in the Development Life Cycle, and recommends strategies for most efficient and effective approvals of regulatory applications for a program.
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labeling regulatory jobs
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