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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. Advises Medicare Compliance Officer regarding the development and implementation of regulatory strategy, potential areas of regulatory concern, and new government/regulatory developments.
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Works in close collaboration with the Project Management and CMC teams and related functions, including discovery, non-clinical development, formulation development, analytical development, Quality Assurance and CMC Regulatory affairs.
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Develop effective collaborations with research project leaders and projects team members, including biostatistics, regulatory affairs, clinical pharmacology, clinical scientists and development operations.
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Ultragenyx is seeking a highly motivated Associate Director Regulatory Affairs CMC, who is inspired to be a compassionate leader in the field of drug development for rare disease patients.
$218,800 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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This role is accountable for the planning and technical execution of the CMC regulatory strategy and for representing Regulatory Affairs-CMC in cross-functional teams and with external partners.
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Associate Director, Public Affairs will serve as a critical Policy & Advocacy team member with responsibility for relations and collaboration with City and State legislators and regulators who make legislative, regulatory policy, and public policy decisions.
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Interact with internal cross-functional teams, including Analytical Development, CMC, Supply Management, Regulatory Affairs, Program Management and Quality Assurance, as well as with Alpine's/Vertex network of external CMOs/contract labs to support company's clinical programs.
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ITS: A career within International Tax Services will provide you with the opportunity to help PwC address their cross border tax needs both locally and globally by managing their global tax rates, finding areas of cost reduction, and responding to inquiries from regulatory authorities.
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Reporting to the Chief Medical Officer, the Senior Director of Regulatory Affairs will be responsible for the development and execution of Sails regulatory strategy and operations.
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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.
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The Deputy General Counsel (GC) for Business Affairs is primarily responsible for legal issues involving complex transactions, intellectual property, revenue generation, advancement, nonprofit tax, and sponsored projects.
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D. graduates in various areas of industry pharmacy including regulatory affairs, medical information/affairs, patient safety, outcomes research, and many other areas. Sample projects: Provide strategic & operational support into the medical affairs plans & activities, investigator-sponsored/collaborative research program, medical education grant program, and medical affairs congress planning.
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Providing guidance on FDA approval pathways and regulatory issues under relevant legislation. Partner, FDA Commercialization/Regulatory. With a team of senior business lawyers with substantial in-house and general counsel experience, Outside GC provides private and public companies and non-profit organizations with outstanding corporate and IP legal services as needed at a fraction of the cost of either hiring a full-time general counsel or relying exclusively on law firm counsel.
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Work closely with the Deputy Commissioner of Policy and Public Affairs and the Press Secretary in service of the goal that the agency is communicating externally to all our constituents, including through the procuring of interpretation services.
$135,742.36 a yearFull-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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The Associate Provost for Student Affairs and Dean of Students (AP/Dean) provides strategic leadership for the MGH Institute of Health Professions in the areas of student services, admissions and other enrollment services, and overall student success.
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regulatory affairs jobs Title: regulatory affairs specialist Company: Pwc in Cambridge, MA
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