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The CMC Regulatory Technical Writer II authors high quality Module 2 and 3 regulatory submissions for both development and post-approval dossiers, change controls and technical reports.
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This position is based in our Princeton, NJ office with onsite presence 60% of the time and reports to the Head of Regulatory Affairs. Minimum of 10 years of experience within Regulatory Affairs (Oncology experience preferred.
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CMC regulatory affairs, or a related field within the pharmaceutical or medical device industry. Specific certifications related to drug-device combination products or regulatory affairs (e.g., Regulatory Affairs Certification) could be advantageous.
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Including at least 3 years of relevant Regulatory Affairs experience, or Advanced degree (PharmD, PhD, MD or DVM) with at least 2 years of regulatory or relevant pharmaceutical/biotechnology industry experience required.
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In addition, to provide technical support and assistance to ESOC on a 24x7 basis. Our focus on combatting climate change through clean energy technology, our new net zero climate vision for 2030 and enhanced commitment to diversity, equity and inclusion; and supporting the communities we serve make this a particularly exciting time to join PSEG. Job Summary The Energy Management System (EMS) is a collection of specialized Electric Utility computer systems used by the Electric System Operations Center (ESOC) for the monitoring and control of PSE&G’s Bulk Electric System (BES.
$88,400 - $140,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Desktop Support Specialist provides a higher level of technical support through analysis and problem solving to facilitate installation, implementation, maintenance, education, and documentation of a variety of computer and software technologies.
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Preference will be given to students who have applied to and have been accepted into the Counselor Education – Student Affairs or Higher Education Administration program by the College of Graduate Studies application deadline.
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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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We are excited to announce that currently we are looking for a 100% remote (work from home—WFH) contract Technical Support Representative – Optos to join our team. With a focus on providing talent for patient support, field/inside sales, medical device support, clinical support, and medical affairs our CSMS division has 10,000+ field professionals in more than 30 countries addressing physician and patient needs.
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Reports To: Vice President, North American Regulatory Affairs and Quality Assurance. The Quality Affairs Director will be responsible for leading the North American GxP compliance efforts across non-production (non-Good Manufacturing Practice/Good Distribution Practice) related areas, including clinical trials, regulatory submissions, and clinical operations.
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This role will develop and lead all medical affairs activities ensuring partnership within the team (medical strategy, scientific communications and publications) all key Medical Affairs functions (Medical Excellence, HEOR, Field Medical, Medical Information) as well as maintaining a high-level cross-functional collaboration across the organization to ensure alignment and One Insmed approach.
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Provide support and leadership to Product Development/R&D, Quality, Regulatory, Operations, Sales & Marketing on all product lifecycle issues, including new product introduction, design changes and product end-of-life issues.
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Licenses & CertificationsSAP S/4 HANA The Open Group – TOGAF Software/Technical SkillsEnterprise Architecture Design toolsSAP S/4 HANA – specifically, P2P, OTC, FP&A, S&OP, IBP (must be proficient in at least three process domains)(CRM) Customer Relationship Management Integration(LES) Logistics Execution System IntegrationJira Issue & Project Tracking Software Other Skills, Knowledge, & AbilitiesBusiness Analysis.
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Assist the Director of Nursing (DON) to ensure that the technical and clinical skills of the Registered Nurses RNs are current that they function within the scope of their licensure, and that nursing actions are not delegated to another provider for which that person is not prepared or qualified.
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Develops solutions for the EBS-C networks that require collaboration with other technical experts on the team such as Software Developers, Database Administrators, Solution Architect and Project Manager.
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regulatory affairs technical writer jobs in Bridgewater, Beech-grove, Indiana
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