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

Closing Date

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