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Successfully interacts within Clinical Data Science, with Clinical Development and Regulatory Affairs groups on a frequent basis. Statistical Programming- Analysis Programming: Statistical programmers work collaboratively with internal colleagues and external vendors to ensure the efficient, high-quality production of analysis datasets and statistical outputs for study reports and integrated summaries in support of Gilead's regulatory, scientific and business objectives.
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Clinical Operations plays a key role in ensuring all Gilead clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of Gilead’s products.
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Prior experience in healthcare and/or digital health marketing with awareness of the regulatory issues and understanding of promotional regulatory requirements. At least 3 years prior experience in search engine optimization (SEO), search engine marketing (SEM), content marketing, email marketing, digital advertising, and social media marketing.
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Knowledgeable in IT compliance and regulatory standards, such as SOX compliance. Ensure compliance with regulatory standards including SOX, focusing on the SaaS portfolio, network, security and data protection.
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We are looking for a Forensic Technologist to join our eDiscovery and Information Governance Legal Team. In your role as a Forensic Technology Lead, you will focus on discovery/disclosure efforts in the various phases of the EDRM model for litigation and regulatory matters, investigations, and all other matters requiring the identification, preservation, collection, processing, and production of data.
$104,000 - $146,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Senior Regulatory Affairs Specialist, Redwood City, CA - Develop strategies for global approvals to introduce new Spinal cord stimulation systems to market, maintain existing products, provide advice on regulatory requirements, prepare worldwide submissions, and negotiate approval with global regulatory agencies.
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The optimal candidate participate will lead the department and also collaboratively work across a team of peers in Clinical, Regulatory, Biometrics, Medical Affairs and Commercial and will be accountable for ensuring safety systems, staff and procedures are in place to support a compliant global pharmacovigilance system.
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Knowledge of state & federal OSHA, US Coast Guard regulations, PSMSC and other safety regulatory requirements for the maritime industry. The Company serves as stevedore and/or terminal operator for a wide variety of maritime cargoes for export and import.
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This position requires a comprehensive knowledge of SAS and CDISC standards, project and resource management, regulatory filing experience, and a broad understanding of the pharmaceutical drug development process.
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This Associate Director will coordinate activities with internal team members and external parties (e.g., regulatory bodies; vendors; consultants) to maintain up-to-date information on regulatory requirements and product submissions.
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For the health and safety of our team members and residents, Oakmont Management Group may require team members to vaccinate, participate in daily screening, surveillance testing, and to wear face coverings and other personal protective equipment (PPE) to prevent the spread of the COVID-19 or other communicable diseases, per regulatory guidelines.
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Collaborate with regulatory affairs to ensure compliance with applicable medical device regulations and standards throughout the development lifecycle. Define project requirements, specifications, and timelines in collaboration with cross-functional teams, including engineers, researchers, medical professionals, and regulatory specialists.
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Provide support in production or validation of summary tables, data listings and graphs required for trial report and clinical development, and CDISC data sets for regulatory submission. This position will be responsible for leading the programming aspect of a project for all programming deliverables from the single study through to regulatory approval.
$160,000 - $175,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Collaborating closely with cross-functional teams, the Senior Scientist will play an integral part in guaranteeing the quality, safety, and adherence to regulatory standards of our products. Excellent technical writing skills and experience authoring development reports, SOPs, regulatory filings, or other documents.
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Oversee environmental, health, and safety disciplines to ensure a safe work environment and to achieve compliance with the Land, Buildings and Real Estate's (LBRE) environmental, health, and safety standards, Stanford University (SU), and governmental regulatory requirements.
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regulatory job Title: sr regulatory affairs associate Company: Thermo Fisher Scientific in Foster City, CA
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