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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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The Digital Content Specialist will fill a role on a creatively talented team of student employees who collectively produce visual content and help manage institutional social media channels for the BSU’s Office of Social Media and Digital Content within the Division of Enrollment, Marketing and Communications.
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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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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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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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In support of this model, roles have been categorized into one of four work location categories: onsite roles, hybrid roles that are a blend of onsite and remote work, remote local roles that are primarily home-based but require some level of purpose-driven in-person interaction and living within a commutable distance, and remote non-local roles that can be effectively performed remotely with the ability to work in approved states.
$88,400 - $140,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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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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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The Luxury Retail Specialist is responsible for representing Mosaic, our clients, and our customers by effectively working in the field visiting retail locations on behalf of our luxury wine/spirits client, including but not limited to, the proper implementation of plan-o-grams, new item placement, stock rotation, building displays, installing POS and completing surveys and audits.
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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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As a member of the R&D Advisory Group, an Implementation Specialist is responsible for ensuring a superior client experience while developing the skills and supervising the work of consulting staff team members.
$77,534 - $108,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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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Benefits: 401(k) 401(k) matching Bonus based on performance Dental insurance Health insurance Opportunity for advancement Paid time off Vision insurance Solaris Pharma Corporation is a leading specialty pharmaceutical company committed to the development and commercialization of high-quality, specialty pharmaceutical products.
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regulatory affairs specialist jobs in Bridgewater, Beech-grove, Indiana
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