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In conjunction with the AVP, Medical Affairs NA - Biologics and Market Access, will be the responsible member of the Sun Pharma medical department in regulatory interactions, ISS and expert advisory board meetings, external professional societies, seminars, and conventions.
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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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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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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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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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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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Key Responsibilities: Collaborate with the head of NA HEOR and cross-functional teams, including members of medical affairs, clinical development, regulatory, market access, and commercial.
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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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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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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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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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4 plus (4+) years of R&D (Clinical Studies, CROs, Central Lab, IRT, IRBs, Wearables, Investigators sites, Medical Affairs, HEOR, CMC and other related ancillary providers etc.) Ensures compliance with all regulatory and reporting requirements related to Supplier Diversity and tracks Supplier Diversity for RFI and RFP.
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As a warehouse associate at Floor & Decor, you are the backbone of our retail location. This policy and the law prohibit employment discrimination against any associate or applicant on the basis of any legally protected status outlined above.
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This position reports to the Dean of Academic Affairs and actively serves students and faculty members to support their information and media needs. The Pennington School is seeking an engaged and passionate Librarian/Media Specialist to begin in August 2024.
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Kelly® Science & Clinical is seeking a Regulatory Affairs Associate for 1 year contract position (with possibility of extension) position at a premier client in Skillman, NJ. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
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affairs job Title: regulatory associate Company: Thermo Fisher Scientific in Skillman, NJ
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