Medicine Development Lead - Pharmaceutical Companyの転職・求人情報 26533794

募集要項

仕事内容: 一部例：
Acts as a single point of accountability for all aspects of a medicine development in Japan from initiation of Japan development to launch in Japan.
Delivers differentiated medicines of value for patients, stakeholders and markets in Japan on time within budget, through an evidence package that supports regulatory approval, market access, and product life cycle in Japan.
Leads the Japan Medicine Development Team.
Serves as the single accountable decision maker to resolve disputes among the J-MDT.
Collaborates with the central Medicine Development Team (MDT) to create strategies that support optimal medicine development.
Serves as the asset level point-of-contact for the central Medicine Development Leader (MDL).
Asset single point of contact and spokesperson to Japan senior management and Japan governance board.
Proactively identifies unmet medical needs that could be addressed through line extensions in Japan.

応募資格

必須: Considerable pharmaceutical industry experience is required (or, for MD, considerable experience as a leading member in clinical research)
Filing experience, JNDA as a core responsibility and have led development programs and deep experience in all phases of product development, especially in late phase development is preferred (or, for MD, experience as an investigator in Phase 2-3 clinical trials)
Experience of working with Japan regulators and regulatory requirements including an understanding of the legal and government frameworks (not mandatory for MD)
Scientific degree or equivalent experience (Life sciences, Pharmaceutical, Medical or equivalent)
Fluent English proficiency

歓迎: nowledge in Respiratory, Immunology/Inflammation, or Hepatology
Master of Science or equivalent. MD, PhD, PharmD preferred but not essential (Life sciences, Pharmaceutical, Medical or equivalent)

休日休暇: Full 2 holiday week system (Sat/Sun) national holidays, New year’s holiday, Annual Leave?