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Early and late-stage regulatory CMC program/project leadership (Phase I/II and Phase III IND/CTA, MAA/BLA) and experience with non-viral or viral vectors is desirable. Work closely with the technical team and regulatory project managers to ensure the achievement of submission deadlines.
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Collaborate with the Project Management and CMC teams and related functions, including discovery, non-clinical development, Formulation, Analytical Development, QA, and CMC Regulatory Affairs. Manage project assignment and work distribution for process development group.
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In the role of Associate Director in PKS you will provide ADME /PK/PKPD project support in the Cardiovascular and Metabolic Therapeutic Area by contributing to the transition of drug projects from discovery to First-in-Human studies and further clinical development.
$151,200 - $226,800 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Extensive experience working as a Project Toxicologist across different therapy areas within the pharmaceutical/biotech project environment delivering pre-clinical toxicology packages and successful marketing for a range of modalities which should include small molecules, peptides and oligonucleotides.
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REQUIRED: bachelor’s degree; three years of experience in stewardship/donor relations, communications, or a related field; excellent interpersonal, project management, planning, analytical, organizational, presentation, and written and oral communication skills; attention to detail; discretion and good judgment with confidential information; and proficiency with computers and standard applications (including Microsoft Word, Excel, and PowerPoint.
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Lead a cross functional project of health data scientists, computational biologist, and biologists in targeting a neurodegenerative disease. Work both independently and as part of a collaborative team to design, plan and execute experiments that support research activities, project goals and platform development.
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Join Takeda as a Scientific Director, Pathology in Cambridge, MA, where you will be responsible for active cross-functional collaboration, interdisciplinary project team participation, scientific leadership in the design and implementation of safety assessment strategies to support program advancement and decision-making, primary evaluation and peer review of pathology specimens and data, preparation and review of regulatory documentation, study reports and manuscripts.
$169,400 - $266,200 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Interpret results for presentation & communication to Asset Leads, VP Finance R&D and Medical, to consolidate key messages and issues for Global R&D senior management for capital expenditures and operating expenditures by nature and by project.
$143,250 - $210,100 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Demonstrated project management and cross-functional leadership experience associated with project and study management, knowledge of Good Clinical Practices (GCPs), monitoring, clinical, and regulatory operations required.
$161,600 - $269,400 a yearFull-timeExpandUpdated 3 days ago - UpvoteDownvoteShare Job
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Primary responsibilitiesFinancial Operations – Perform central accounting functions including capital project oversight, payroll approvals, space management, procurement, reimbursements, or other functions; serve as the Asset manager overseeing all functions of the Oracle asset system; oversee access to financial systems, providing training as needed; identify operational challenges; research and implement solutions.
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Serve as a CMC strategist and project leader for projects/programs, providing regulatory assessments and developing regulatory strategies with input from the Executive Director Regulatory Affairs CMC.
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This opportunity will offer you the chance to grow your Regulatory Affairs CMC expertise across a range of disciplines such as nucleic acid therapeutics, lipid-nanoparticle drug delivery, viral delivery systems, and a range of cell therapy products.
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The ideal candidate will have extensive experience in process development, manufacturing, and validation, as well as project and vendor management, authoring of regulatory filings, and a strong understanding of cGMP compliance with the business acumen to interface with multiple key external partners.
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6+ years project management experience as a statistical programmer. Provides technical and project management leadership in SAS programs and applications designed to analyze and report complex clinical trial data and for electronic submissions of data in CDlSC format.
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Lead the development and implementation of analytical development strategies, ensuring alignment with overall project goals and efficient resource utilization. Job Overview: The Director of Analytical Development will lead the creation and execution of strategies for high-throughput, high-quality testing of iPSC Cell Therapy products, developing analytical methods and streamline method development and transfer processes.
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project job Title: director in Needham, MA
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