非公開
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)
高い開発力を持った成長中グローバル希少疾患メーカーです