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Preferred Qualifications: Knowledge of: Support services network, including programs and services offered by the Executive Office of Elder Affairs, Massachusetts Rehabilitation Commission, Department of Mental Health, Department of Developmental Services, MassHealth, Home and Community Based Waiver programs, and other Health and Human Service organizations.
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In collaboration with Academic Affairs, responsible for understanding and assessing teaching and learning needs; and making recommendations on how the learning management system can be used to support those needs.
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The Senior Director of Regulatory Affairs Chemistry, Manufacturing, and Controls (RCMC) will provide strategic as well as operational leadership of global CMC activities related to Cell & Gene Therapy (GCT) leading to successful registration and life-cycle management of unique and technologically complex products.
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Work with the various departments on campus, both within and outside Student Affairs to provide educational opportunities around issues of religious diversity, spirituality, and ethics to further the development of students.
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Cross-functional clinical processes, including data management, biostatistics, medical writing, drug safety/pharmacovigilance, and regulatory affairs. Negotiates cross-functionally, successfully motivates and influences (Clinical Development, Regulatory Affairs, CMC, QA, Pharmacovigilance, etc.
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Minimum of 6 years of regulatory affairs experience in the biopharmaceutical industry, with a focus on rare diseases and orphan drug development. Provides support to regulatory affairs reviewers for due diligence initiatives, including opportunity and risk assessment.
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Provides legal support and guidance to the government affairs and funding teams, including government contracting, grant application and overbuild challenge review and drafting for the Broadband Equity, Access and Deployment (BEAD) Program and other local state and county funding programs.
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As part of the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs – Pharmaceuticals. Leads the Early Development Pharmaceuticals GRA CMC regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM stages.
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Closely collaborate with Clinical Operations, GPS Operations, Regulatory Affairs, and applicable vendors for seamless PV processes, serving as a leader, mentor and ambassador for GPS. This includes collaborating with Clinical Research, Clinical Operations, Medical Scientific Affairs, and/or vendors to develop and monitor the clinical trial safety.
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An advanced clinical degree (MD, DO, PhD, PharmD) and a minimum of 3 years in medical affairs or a related field. We are looking for a dynamic Director of Medical Affairs with a passion for medical communication and supporting scientific partnerships.
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Skills and Qualifications Doctorate degree & 2 years of MSL/Medical Affairs experience; Master's degree & 3 years of MSL/Medical Affairs experience Pharm. Identify and facilitate opportunities for data generation activities through proposals for posthoc analyses, Investigator-Initiated Trial (IIT), and Medical Affairs-sponsored studies for research that is aligned with Galderma's strategic focus in a compliant and collaborative manner with home office colleagues.
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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.
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Coordinate/Interface across project packages including HSE, stakeholder and government affairs, permitting, marine affairs, engineering, partnering, finance, legal, procurement, construction and commercial analysis as needed to ensure effective development of the offshore wind project.
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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 Sr. Medicare Compliance Program Manager is a key member of the Legal, Regulatory Affairs and Compliance team to support the organizations Medicare Advantage line of business. The Sr. Medicare Compliance Program Manager will be a member of the Medicare Advantage cross-functional project team and their role will be to ensure compliance, help to identify and mitigate risks of noncompliance and provide regulatory requirements and guidance on how to implement, operationalize and optimize.
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affairs job Title: regulatory affairs project manager Company: Aerotek in Cambridge, MA
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