Principal Responsibilities
- Contribute to the TA strategy through researching the medical environment, identifying and building relationships with KEEs, and through the planning, preparation of advisory board meetings.
- Participate in program meetings to stay updated on the latest progress and provide expert opinions as needed to support team discussion and decision-making.
- Act as a point of contact for global clinical development expert
- Review and provide expert input on program related documents (e.g. protocol, IB)
- Review and/or provide expert input on documents for regulatory interactions (e.g. briefing document for PMDA, Orphan drug designation application)
- Review and provide expert input on relevant parts of filing documents (e.g. CTD, J-PI, RMP).
- Prepare responses to clinical part of PMDA inquiries in collaboration with JPTL and other JPT members.
- Contribute to discussion of PADG team in collaboration with JPTL and medical affairs.
- Review and expert input on publication strategy and contents/quality of publications.
- (In case of a Japan stand-alone study) create study documents (e.g. protocol concept sheet)
Qualifications
- Minimum of eight (8) years of experience in drug development in pharmaceuticals, biopharmaceuticals, or biotechnology.
- Experience in Phases 1 to 3 as a clinical scientist.
- (Preferred) Experience working in a global pharmaceutical company
- Extensive experience as a clinical scientist including KEEs engagement, AdB meetings, preparation of clinical documents (e.g. protocol, IB), regulatory interactions, filing preparation and post-filing inquiry resolution.
- Knowledge of local regulations and guidances
- English skills that enables communication with global team.
Education
- Life Science related bachelor's degree
Others
- Business Trip Available; Visit to mainly domestic medical institutions/doctors, domestic conferences, etc.
Date Posted
08-8月-2025
Closing Date
Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact Alexion participates in E-Verify.
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