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Firm Type: Law Firm, Experience: 4 Years, A law firm is seeking a Securities Litigation Associate Attorney to join their team in Florham Park, NJ. The ideal candidate will have 4-6 years of substantive experience in securities litigation and regulatory practice, working on a variety of matters, including arbitrations, regulatory enforcement actions, and compliance issues.
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With 5 years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience. Job Title: Regulatory Studio - Associate Director, Precision Medicine & Digital Health.
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Partner with Drug Metabolism and Pharmacokinetic (DMPK) and Bioanalytical (BA) Subject Matter Experts (SMEs) to author, review and track regulatory documents. Understand the impact of DMPK/BA and interdependencies with other functional teams within the enterprise including Pharmacology, Toxicology, Clinical and Regulatory disciplines.
ExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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Interface effectively with all other BMS internal stakeholders: Global Medical Affairs functions and other departments, including Commercial, Clinical Research and Development, Regulatory Affairs, Managed Care, Pharmacovigilance, Market Access, Statistics, Translational Research/Development, Project Leadership, etc.
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Regulatory, Legal/Compliance, Medical, Marketing, Creative Agencies. Perform other regulatory tasks as assigned. Intra-Cellular Therapies is a biopharmaceutical company committed to the development of novel CNS drugs, leveraging innovative technology based on the pioneering efforts of ITCI co-founder and Nobel laureate, Dr. Paul Greengard.
Full-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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On-Board Scientific is hiring a Nonclinical Regulatory Document and Scientific Writer based out of either New Brunswick, Lawrenceville or Summit, NJ! Qualifications: At minimum, a Bachelor’s degree in Chemistry, Biology or related science with a strong background in DMPK and BA including knowledge of the FDA GLPs. + years of Regulatory drug development experience Experience with CTD documents and nonclinical study reports for submission to global regulatory agencies.
$57.78 - $62.5Full-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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The Medical & Scientific Affairs Lead - OTC provides expert medical and scientific support to multiple departments and interdepartmental teams including R&D cross functions, Innovation, Marketing /commercial, Clinical Development, Regulatory, Category, BU’s etc.
$297,238 a yearFull-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Provide scientific and medical expertise to cross-functional teams, including research and development, regulatory affairs, market access, and commercial teams. Ensure compliance with regulatory and ethical standards in all medical affairs activities.
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Manager, Regulatory Affairs: Base Salary Range $90,000 - $120,000. Onboard and conduct Veeva system and standard operating procedure (SOP) training for Internal and External parties. Ensure all promotional materials are properly vetted through the review process utilizing the cloud-based review system (Veeva PromoMats.
$120,000 a yearFull-timeExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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Kept up to date on Digital Health technology regulatory requirements and worked on a digital pathology or digital health product in a drug. " Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests, digital health and other devices to enhance the value of our pharmaceutical products across therapeutic areas.
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As a member of the Risk & Regulatory Advisory team, you will advise financial institutions on a broad range of credit risk management topics including organization and governance; credit process optimization; risk rating model design, build and implementation; credit regulatory assessments; and Current Expected Credit Losses (CECL) process and tools.
$232,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Our client, a leading pharmaceutical company, is hiring a Nonclinical Regulatory Document and Scientific Writer, on a contract basis. The post Nonclinical Regulatory Document and Scientific Writer appeared first on TSR Consulting Services.
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Initial draft authoring of scientific content for Common Technical Document (CTD) Quality sections and responses to health authority questions aligned with regulatory strategy for cell therapy clinical CMC regulatory submissions based on high quality technical reports.
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Assist with quality review of DMPK reports that are generated by DMPK scientists by fully reviewing the raw data outputs/electronic notebooks and ensuring validity and quality of reported data in the reports, in addition to reviewing DMPK regulatory documents, editing of nonclinical study reports for regulatory acceptance and adherence to company templates, SOPs, DMPK/BA methods, work practices and FDA GLPs, as applicable.
$57 an hourExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams. Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions.
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regulatory affairs jobs Company: Mallinckrodt Pharmaceuticals in Basking Ridge, NJ
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