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Manager Clinical Trial Information Disclosure
3 months ago
Join a Legacy of Innovation 110 Years and Counting
Daiichi 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.
Summary
The Clinical Trial Information Disclosure Manager leads company operational activities to comply with US, EU, Japan and other regional disclosure regulations and the WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the company's compliance with current disclosure requirements and participates in the strategic planning for future change. Subject matter expert on global clinical trial registration, result posting, plain language summary, redaction and data sharing requirements.
Responsibilities
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)
Bachelor's Degree (State Examination, Diploma) pharmacy, biology, chemistry, medicine, or equivalent requiredMaster's of Science Degree preferredExperience Qualifications
4 or More Years Experience with a Bachelor's Degree in the pharmaceutical industry and in the area of clinical trial information disclosure highly desirable.1 or More Years of experience with a Master’s of Science degreeWorking knowledge of key global laws, regulations and guidelines relating to clinical trial documents and data disclosure is desirable. preferredGood general knowledge of key global pharmaceutical legislation. preferred
Travel - Ability to travel up to 10% Standard office based physical demands, and some international travel for internal and external workshops / interactions with external regulators, industry bodies and key stakeholders. Ability to travel within US, and to the EU & Japan.
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. 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.