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This position is based in our Princeton, NJ office with onsite presence 60% of the time and reports to the Head of Regulatory Affairs. Minimum of 10 years of experience within Regulatory Affairs (Oncology experience preferred.
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In depth understanding of compliance and regulatory requirements for pharmaceutical Medical Affairs, R&D and Commercial work. Biotech / Pharmaceutical industry experience, with strong understanding of solid tumor drug development and medical affairs function.
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Reports to HCP Strategy Lead. Collaborates with cross-functional teams, including sales, marketing, medical affairs, market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs, and other relevant NNI departments to ensure alignment of HCP brand objectives and strategies, effective execution of HCP experience strategies and transparent communications outside the department.
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Our Market Access and Public Affairs professionals ensure that the latest therapies and products reach the people who need them most, by creating an environment where innovation and chronic disease management drive optimal health outcomes.
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Our clients include DHS, DHA, DoS, USMC, US Army, HHS/Indian Health Service, Department of Interior, Bureau of Indian Affairs, Bureau of Indian Education, among many more. The Senior ServiceNow Engineer to support the US Army Corps of Engineers Revolutionary IT Services (USACE RITS) to manage and oversee the Configuration Management Database (CMDB) to inventory and troubleshoot existing information, as well as, mange integration and discovery processes such as generating patterns in discovery and creating or modifying new and existing patterns in Discovery.
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The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions.
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License to practice Speech Language Pathology issued by PA Bureau of Professional and Occupational Affairs is preferred. Will consider strong Clinical Fellowship Year (CFY) candidate for Long Term Substitute (LTS) positions in the Related Services program.
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Cross-functional collaboration/interaction with Clinical Affairs, R&D, Regulatory, Quality, OEC, Legal, Global Marketing & Commercial teams. Supporting the Director of Global Scientific Affairs, in conjunction with the Sr. Manager and Project Manager in Global Scientific Affairs, with KOL management as it relates to investigator-sponsored studies (ISS) and/or collaborative research studies (CRS.
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The Rapid Cycle Analytics (RCA) Lead Data Scientist role sits within the Clinical Data Science and Evidence (CDSE) team, which is part of CMR. This role interfaces with internal stakeholders from Health Economics and Outcomes Research (HEOR), Real-World Evidence (RWE), Medical Affairs, Clinical Trials Operations, Market Access, and a few other teams to respond to quick turnaround data analytics requests.
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A demonstrated track record of successful business experience in other related functional areas, such as Health Care Compliance (HCC), Medical/Scientific Affairs, Sales, Marketing, Legal, etc. Identify issues and facts that may be impacted by and subject to applicable laws, regulations, guidelines and company policies (including FDA regulatory promotional practice laws, regulations, policies, guidelines and enforcement trends; fraud and abuse laws and HCC policy); and helping to develop alternatives to avoid any misperception in the respective communication while achieving the desired communication outcome outcomes.
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Ongoing demonstration of compliant collaboration, teaming and pull thru across stakeholders (Medical Affairs, Marketing, Sales Leadership and Market Access) to coordinate a consistent company approach to key customers.
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Interacts internally with team representatives from PCOR, Finance, Brands, Medical Affairs, HEOR, Commercial Pipeline, Field Sales, Account Management, Analytics, Investor Relations, Value Communication and Contracting Strategy colleagues across all franchises, and all others, including global colleagues/counterparts, on a routine basis.
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Deloitte Risk and Financial Advisory's Financial Services Industry (FSI) Risk, Data and Regulatory professionals help organizations identify the regulatory changes impacting their business and implement effective and efficient processes to manage regulatory, capital, liquidity and interest rate risks, respond to evolving regulatory environments and implement programs, measures, and tools to help clients with a specific focus on risk, data, and regulatory processes.
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Certificate of Clinical Competence in Speech-Language Pathology (CCC-SLP) is required. The Speech-Language Pathologist (SLP) will access needs, plan strategies and deliver evidence based supports to students with communicative disabilities across a variety of educational settings to include general and special education classrooms, specialized schools and community settings.
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Bachelors degree in Business Administration, Economics, International Affairs, or a related field. Bachelors degree in Business Administration, Economics, International Affairs, or a related field.
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affairs job Title: regulatory Company: Thermo Fisher Scientific in Lawrence, NJ
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