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Strong tactical familiarity with the design, overseeing and assessment of clinical trials and with other medical affairs activities (expertise in clinical trial methodology and conduct, GCP principles, medical product support activities, publications, ISS, continuing medical education.
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Requirements: BSc or MSc level degree preferably within the life sciences (PharmD, PhD preferred) Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred) Prior experience of direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA) A solid understanding and experience in drug development including early and late development is highly preferred.
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Requirements: BSc or MSc level degree preferably within the life sciences (PharmD, PhD, or MD preferred) Minimum of 10 years of experience within Regulatory Affairs (Oncology experience preferred) Direct interaction/negotiation skills with regulatory authorities (e.g. FDA, EMA) A broad knowledge of development and life-cycle management is preferred.
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Minimum of 10 years of experience within Regulatory Affairs (Oncology experience preferred) As a key member of the Regulatory Affairs leadership team, you will play a critical role in ensuring compliance with global regulations and driving the growth of our company.
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Regularly interfaces with team members in R&D including Biostatistics and SAS Programming staff, Data Management, clinical research and operations teams, regulatory affairs, clinical pharmacology, medical writing, medical affairs and quality management.
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The Director, Corporate Counsel – Rare Disease will serve as the legal advisor to the US Commercial, Patient Advocacy, Public Affairs, Regulatory, and Medical Affairs teams supporting our Rare Disease Franchise, and will coordinate legal services with the attorney responsible for Canadian support for the Rare Disease Franchise.
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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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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.) Hybrid Employee Value Proposition: Join our dynamic and expanding mid-size company in the role of Sr. Manager, Outsourcing and Vendor Management.
$159,800 - $188,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Associate Director, Worldwide (WW) Medical Affairs, Rheumatology is a core member of the WW Medical Rheumatology team and Psoriatic Arthritis Launch team. Associate Director, WW Medical Affairs, Rheumatology page is loaded.
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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. SUN Pharma, Princeton, New Jersey (ONSITE: Hybrid 3 days in office; 2 days remote)Director, Health Economics & Outcomes Research Summary: Sun Pharmaceuticals, one renowned global specialty generic pharmaceutical manufacturer, is looking for a dynamic, experienced, and motivated professional to support the planning, design, and execution of HEOR and RWE generation programs.
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To be successful, you must work in collaboration with Regulatory Affairs, Marketing, Market Access, R&D, Professional Education, Sales Training, Global Commercial Teams, Enterprise, and other functional teams.
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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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The Scientific Director, reporting into the Global MA Product Head Mogamulizumab, will support the Global MA Product Head in the planning and execution of Global Medical Affairs activities for mogamulizumab in hematology-oncology, building and facilitating highly effective collaborations and alignment with regional and country medical leadership, as well as other key cross-functional stakeholders.
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This is done in alignment with the Global Medical Affairs and corporate strategy. The Senior Director of Medical Affairs in Oncology provides exceptional medical leadership for creating and implementing medical affairs strategies, plans, and tactics for the current products and pipeline portfolio in Oncology for the North American region.
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affairs job Title: sr affairs in Lawrence, NJ
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