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Expertise in commercial healthcare and FDA regulatory law, specifically related to market access, pricing and price reporting, patient support, government contracting matters, and other laws and regulations related to the development and commercialization of pharmaceutical products.
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Integrate clinical pharmacology knowledge with a broad understanding of and collaboration with related disciplines such as clinical development, biostats, regulatory, nonclinical, and research to support and impact development decisions.
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Position SummaryThis position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
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The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases ā cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia ā and continues to advance clinical and research programs in these diseases.
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A minimum of 15+ years' experience in pharmacovigilance leadership roles, including Head of Drug Safety/Patient Safety/ Product Safety & Pharmacovigilance for a bio-pharmaceutical/pharmaceutical company (minimum of 5 years), medical monitoring within a global CRO, and/or clinical practice in a relevant therapeutic area.
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Under the supervision of the Senior Director for Quality Assurance and Regulatory Compliance, the Program Manager, Clinical Regulatory Compliance & Accreditation will support various initiatives in the areas of clinical regulatory compliance.
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Manage a broad range of regulatory and compliance matters, including issues related to the Anti-Kickback Statute, Stark Law and/or False Claims Act, Medicare and Medicaid reimbursement, data privacy, drug diversion, licensing, research compliance, telehealth, and general compliance and risk management.
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PhD in pharmacology or toxicology with at least 10 years of industry experience, a Masterās degree with a least 14 years industry experience, or BS with 16 years working as a research project member at a pharmaceutical company.
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This role collaborates cross-functionally with key cross-functional partners including other GMA functions, Clinical Development/Operations, Regulatory Affairs, Corporate Communications/IR, Legal, Market Access and Commercial, and Research.
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Commitment to safety, environmental stewardship, and regulatory compliance in metallurgical operations. Analyze process data meticulously, ensuring safety protocols and regulatory compliance.
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Requirements Requires an advanced degree in Pharmaceutical Sciences, Chemistry, Materials Science, or related field with 5+ years of experience in process development and manufacturing of peptide and oligonucleotide APIs including PMOs. Experience with solid phase peptide/oligo synthesis preferred.
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The Director, AML Modeling is part of the Compliance Analytics team which is responsible for overseeing risk management strategies to prevent, detect and disrupt usage of Bank products and services for the purposes of money laundering, terrorist financing, bribery, corruption and economic sanctions avoidance.
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Responsible for ensuring development programs are operating in compliance with the EU/FDA regulatory requirements and in compliance with company standards. Thorough knowledge of FDA and EU cGMPs and pharmaceutical manufacturing and analytical requirements.
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A PhD and/or MD degree with postdoctoral experience and a minimum of two years of research in renal biology and physiology, preferably in the pharmaceutical or biotechnology industry. Analytical Skill, Analytical Skill, Analytical Thinking, Chemical Biology, Chemistry, Clinical Trials, Collaboration, Communication Skills, Curiosity, Data, Data Analysis, Design Of Experiments, Detail-Oriented, Drug Development, Drug Discovery, Ethics, Gene Therapy, Immunology, Inventory Management, Laboratory, Lifesciences, Machine Learning (Ml), Management, Medical Research, Molecular Biology {+ 10 more.
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Experience with GxP compliance requirements and FDA regulatory guidelines as applicable in support of biologics drug development programs. You will be reporting to the Senior Director of Analytical Development and provide technology development, strategic leadership, scientific and technical expertise in protein biologics method development, optimization, and qualification/validation.
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research pharmaceutical company regulatory compliance jobs Title: senior director in Waltham, MA
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