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Advanced life science degree or certification in Regulatory Affairs Sciences preferred. Experience and solid knowledge of Pharmacovigilance specificallyProficiency in one or more of these additional areas is a plus: CMC/Mfg., Clinical development and trial execution, Regulatory, Real-World Data and Real-World Evidence, Cell and Gene Therapy, Medical Device, IVD/CDxExperienced in understanding and interpreting regulatory guidelines and documents.
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Develop and file, in tandem with the General Counsel and the Compliance Office, mandatory insurance regulatory filings related to ERM, including but not limited to the Enterprise Risk Report and the Own Risk and Solvency Assessment (ORSA) Summary Report.
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Conduct comprehensive research on ESG trends, regulatory frameworks, and best practices across various industries in support of sustainability strategy and related initiatives; deliver decision-useful information to senior management and provide valuable insights to our program.
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This individual will be responsible for delivering CMC documentation (Dossier and supporting documents) to support the regulatory strategy for the Cell Therapy clinical portfolio from early stage through registrational application.
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Responsible for and manage all regulatory compliance (DOT, OSHA, BIC, DSNY, NYDEC/ NJDEP, etc.) Serve as a regulatory resource for the market area. Bachelors degree in relevant field (Safety, Industrial Hygiene, Engineering, Environmental Science) or equivalent combination of education and technical experience.
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Partnering with cross functional teams internally including, but not limited to: Brand Marketing, Customer Teams, Customer Strategy, Shopper Insights, Visual Merchandising, Category Management, Creative Solutions, Digital Activation, Media Services, Legal & Regulatory, and others, as necessary, to align objectives across all key stakeholders to enable the successful execution of shopper marketing programs.
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Kelly® Science & Clinical is seeking a Regulatory Affairs Associate for 1 year contract position (with possibility of extension) position at a premier client in Skillman, NJ. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
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Interface with project managers, real estate, construction, field operations, engineering, sales, marketing, finance and regulatory to ensure that our network quality and financial objectives are met.
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He/she/they manages the writing of response to CMC questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts or CMOs. He/she/they defines and manages the compilation of the documentation, required for the authoring by reaching out to appropriate internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global.
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Ensures the charging/coding aspects of the clinical Epic systems meet regulatory and hospital pricing guidelines. Coordinates with Patient Financial Services, Health Information, and other coding professionals to ensure the codes contained in the CDM are accurate and in compliance with regulatory and/or contractual guidelines for accurate billing.
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As a Sales Associate, you act as a brand ambassador bringing your own personal style, passion for the product and welcoming energy to the sales floor each day. You’ll collaborate with your team members and managers to drive the business, jump in on tasks that help create a seamless customer experience, and bring a collaborative, kind, and inclusive energy to the sales floor.
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Key partnerships include working closely within GCDS, with global medical affairs, market access as well as partnering outside with other departments such as with regional commercial and scientific analytics and US Real World Value & Evidence (RWV&E), Global Epidemiology, J&J Technology Data Sciences, Janssen R&D Data Science, and others.
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This role requires a strong leader with a deep understanding of commercial patient services, pharmacovigilance, quality assurance, and regulatory compliance. As a Quality and Compliance Team Lead, you will serve as a liaison to key clients, where your leadership and expertise will contribute to the continuous improvement of our drug safety processes, regulatory and contract compliance, and overall patient safety.
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The Route Service Delivery Driver's primary responsibilities are to provide premium customer service to residential, commercial, and retail customers, accelerate growth through upselling, manage account information, and work safely.
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Collaborate as appropriate with Everest’s Chief Compliance Officer in monitoring and updating compliance policies and procedures governing disclosure requirements worldwide; assist with the design of related compliance training; develop strategies for efficient, effective compliance with legislative and regulatory requirements; and participate in internal investigations as needed.
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regulatory affairs jobs Title: retail sales associate Company: Marshalls in Bridgewater, NJ
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