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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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This role will involve extensive cross-functional collaboration with teams including Medical Affairs, Regulatory Affairs, Legal, Sales, Market Access, and Insights & Analytics. Cross-functional collaboration with Medical Affairs, Legal, Regulatory, Patient Services, Market Access, Data & Analytics, Market Insights, Competitive Intelligence, and US Commercial Field teams to support promotional activities.
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Broad experience in US and Global Regulatory Affairs, including experience with INDs, BLAs/NDAs, MAAs, Pediatric Investigation Plans, Orphan Drug designations, rare disease drug development, innovative trial design and/or expedited regulatory pathways.
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These activities will be performed in cross-functional collaboration with a range of partners throughout the organization, including the US Market Access, US Medical Affairs, Medical Outcomes Science Liaison (MOSL), Public Policy & Government Relations, and US Regulatory Affairs teams.
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Ability to integrate public policy advocacy with public affairs, communications, business strategy and corporate development. Experience working in state government or leading policy or public affairs work for third-party organizations (e.g., lobbyist or running campaigns.
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Liaise directly with internal customers (Biometrics, Clinical Operations, Safety/Pharmacovigilance, Regulatory Affairs, etc.) Experience in supporting study-level audits and regulatory inspections.
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Regulatory Affairs Credential (RAC-Drugs) is an advantage. Represents NRWS on cross-functional project teams to plan and communicate about nonclinical regulatory submissions.
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Deep knowledge of Regulatory Affairs, FDA, and EU GMPs, particularly in relation to the development, manufacturing, and distribution of veterinary medicinal products. Collaborate closely with Product Development, Manufacturing Sciences & Technology, Regulatory Affairs, Site Quality (QA and QC), and both Internal and External Manufacturing teams to ensure quality integration.
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Preferred knowledge in thermal analysis, X-ray powder diffraction, contributions to synthetic chemistry, and regulatory documentation. Proficient in organic chemistry tools (HPLC, LCMS, GC, NMR) and software (ChemDraw, Excel.
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The Senior Director monitors and supports teams responsible for study start-up activities, site activation and maintenance, compliance with all regulatory requirements and Federal guidance, subject accrual and management in close coordination with physician investigators, nursing, finance, and regulatory operations.
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In-depth knowledge of value-based care models, healthcare reimbursement methodologies, and regulatory requirements (e.g., MACRA, MIPS, ACOs). Monitor and analyze actuarial data to ensure alignment with population health objectives and regulatory requirements.
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Oversee and manage all financial and regulatory matters related to the health center’s 340B and Retail Pharmacy. The CFO will be leveraging their expertise in accounting, finance, and strategic planning, and will ensure fiscal responsibility, regulatory compliance, and alignment with organizational goals.
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MedPro is one of the largest recruiters of therapists and nurses from outside the U.S. MedPro currently has contracts with numerous organizations to service a multitude of facilities in the U.S. The company counts among its clients prominent healthcare facilities and organizations such as the Department of Veterans Affairs,HCA, University of Miami Hospital, and Tenet Healthcare.
$3,006.98 a weekFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Collaborate with cross-functional teams, including analytical development, formulation development, quality assurance, and regulatory affairs, to ensure seamless project progression.
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CIB Trading Model Validation Associate Boston, United States of America The Associate, Risk Modeling is responsible for executing model risk management activities consistent with the enterprise model risk management framework, industry best-practice and regulatory guidance.
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regulatory affairs jobs Title: regulatory affairs project manager Company: Aerotek in Boston, MA
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