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Director, Medical Affairs
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Director Medical Affairs
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Manager/Sr. Manager, Medical Affairs
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Medical Science Liaison, Medical Affairs
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Medical Science Liaison, Medical Affairs
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Senior Director, Medical Affairs
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Associate Director, Medical Affairs
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Medical Affairs Manager
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Analyst, Medical Affairs Grants and Sponsorships
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argenx New York, United States OTHERThe Global Medical Affairs and Evidence Generation group delivers ambitious, patient-focused cross-regional and cross-indication medical strategies, driving data generation and dissemination, to maximize patient benefit from argenx products. · The Global Medical Affairs Medical ...
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Argenx New York, United StatesThe Global Medical Affairs and Evidence Generation group delivers ambitious, patient-focused cross-regional and cross-indication medical strategies, driving data generation and dissemination, to maximize patient benefit from argenx products. · Is this the role you are looking fo ...
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Associate Director, Medical Affairs
1 week ago
Mitsubishi Chemical Group Jersey City, United StatesOverview · Entrepreneurial Spirit, Rooted in Tradition . Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, which touts a storied reputation more than 300 years in the making. Our parent company - one of Ja ...
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Associate Director, Medical Affairs
3 weeks ago
Mitsubishi Tanabe Pharma Jersey City, United StatesOverview: · Entrepreneurial Spirit, Rooted in Tradition. Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, which touts a storied reputation more than 300 years in the making. Our parent company - one of Ja ...
Clinical Trial Manager, Global Oncology Medical Affairs - New Jersey, United States - Daiichi Sankyo, Inc.
Description
Join a Legacy of Innovation 110 Years and CountingDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology.
With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people.
Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all Global Oncology Medical Affairs (GOMA) Company Sponsored Studies (CSS) and Medical Access/Expanded Access (MAP)/(EAP)activities in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.
Responsibilities Clinical Operations Study/ Program ManagementCompany Sponsored Studies (CSS)Support the preparation, set-up, and execution and reporting of all global oncology medical affairs operations clinical trial activities, ensuring adherence to timelines, budgets, project, and quality plans, and relevant ICH/GCP Guidelines Review protocols to ensure designs are implementable to efficiently achieve the objectives.
Support activities to drive adherence to timelines, program objectives and monitoring plans.Accountable for accuracy and timeliness of information in all data management activities, databases and tracking systems.
Company Sponsored Studies (CSS) and Medical Access/Expanded Access Program (MAP)/(EAP)
Support the oversight of the overall global oncology review process of PhIV company sponsored studies per the Standard Operating Procedure (SOP) (regional review, Global review, tracking of milestones as per contract).
Ensure the global clinical operations systems for management of company sponsored studies review and approvals are current and accurate.Liaison and reporting on study activities with other relevant GOMA functions and the Global Medical Affairs Team.
Ensure regular updates provided to Study Lead on trial metrics, data, and quality.
Establish strong partnership with Functional and Regional Operational managers to drive operational excellence with the required functions, in regions and countries for all GOMA clinical activities.
Process/Policies/Compliance~ Provide input to process standards and tools to achieve excellence in trial operations and management.
Monitor and ensure compliance and highest quality standards in all GOMA clinical operational activities.
Support the development of clinical operations related to Corrective and Preventative Action (CAPA) plans for issues of non-compliance if applicable.
Bachelor's Degree required Experience QualificationsMedical Affairs experience preferred
~ Project Management experience preferred
~ Ability to travel up to 20% Standard office based physical demands, minimal travel.
Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.