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Principal Duties and Responsibilities Implement at the site-level, system infection prevention and control goals, plans, and standards consistent with the clinical, administrative, regulatory/legal requirements and objectives of the organization.
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Author, review and strategically impact CMC sections (Pre-IND, IND, BLA, & MAA submissions)Manage upstream and downstream scientistQualifications:M.S or Ph. D. in Pharmaceutical Sciences or a related scientific field w/ ideally 10 or more years of industry experience & prior management experienceExperience working cross functionally with senior leadership (QC, Analytical, Manufacturing, Regulatory, Business Development, etc.
$210,000 - $240,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This would be a full-time role with a hybrid schedule of 2-3 days/week in their office in Marlborough, MA. In this role, you will work very closely with engineering teams, marketing, regulatory, R&D, and more to lead the full end-to-end product management process for both new and existing offerings.
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Collaborates with GCP Operational Quality, PMSO (Reg. Intel) and Audits, Inspection Management and relevant stakeholders to define regulatory inspection readiness strategyAdditional TasksIdentify areas of improvement, participate in continual quality process improvement initiatives and foster best practicesMay own CGT standards.
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Maintain awareness of current trends in HR technology and understand statutory and regulatory requirements affecting HR, Benefits, Recruitment, and Payroll systems. Our immersive understanding of these industries – combined with our expertise across high-stakes litigation and dispute resolution, world-class regulatory compliance and advisory services, and complex transactions – sets us apart.
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The Clinical Trial Manager, Site Start-up will lead internal process improvements related to study start up activities to ensure clinical trials are executed with high quality standards in compliance with regulatory requirements, GCP, and company SOPs. This role is based in our Waltham, MA headquarters.
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Develop a Site Initiation Management Plan and coordinate regulatory and ethics committee submissions and perform day to day management of the study start up activities for clinical studies. Responsible for external outreach with KOLs and key clinical trial sites to provide feedback on study feasibility and study start up activities.
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Clinical Trial Initiation Manager will deliver high quality and timely global study start-up. Oversee the informed consent process and translation of study required documents and participate in the development of study start up plans.
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The Clinical Trial Manager, Site Start-up will serve as an expert in study start-up practices by initiating efficient start-up activities and removing obstacles for study teams. Provides internal expertise in the early planning of study start-up to ensure proposed CRO timelines and committed milestones are accurate and achievable.
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Experience with biomarker assay development, validation, and regulatory submissions (. Cross-Functional Collaboration: Collaborate closely with clinical development, translational medicine, biostatistics, regulatory affairs, and external collaborators to integrate biomarker strategies into clinical programs.
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You are results-oriented and have comprehensive knowledge of the drug development process and have a demonstrated record of successful regulatory submissions (IND, CTA, NDA/MAA, etc.) You will be the primary contact to interface with FDA and will lead cross-functional teams to deliver domestic and international regulatory submissions including IND, CTA, NDA and MAA submissions.
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Responsibilities: Manages activities of workers compensation and disability claims, case management and utilization review according to established policies and procedures and applicable legal and regulatory guidelines.
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Stay well informed on policy or programmatic developments affecting municipal governance and service delivery; work with the Director and MAPC’s Government Affairs team to seek legislative, regulatory, and administrative reforms to enhance the effectiveness and efficiency of local government.
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Counsel key stakeholders on legal, regulatory and policy developments such as Inflation Reduction Act, fraud and abuse, privacy, government price reporting and antitrust. Assist with a broad range of other healthcare regulatory matters including funding requests and client and vendor training.
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Collaborate with colleagues in other units, including Principal & Major Gifts, Annual Giving, Planned Giving, Corporate Partnerships, Foundation Relations, Donor Relations, Jimmy Fund, and Fiscal & Regulatory Management teams to maximize donor engagement and philanthropic commitment.
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regulatory job Title: principal Company: Parexel in Cambridge, MA
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