Position Overview
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 expertReview 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 JPT...