POSITION SUMMARY:
This position is accountable for leading or contributing to the development of clinical evidence generation and dissemination strategies across assigned projects.
Essential / Principal duties and responsibilities:
List the major responsibilities and duties of this position.
1)Contribute to evidence generation strategy with collaboration relationships with all cross-functional partners (e.g. Marketing, Medical Affairs, Regulatory Affairs, HEMA, etc) as a clinical member.
2)Drive assigned clinical projects leading to delivery of clinical project commitments (delivery on time, within budget and in compliance with regulations and SOP) å
3)Contribute to build team’s interface and collaboration with key opinion leaders, investigators, IRB’s/ECs, regulatory agencies, societies, associations, etc;
4)Contribute to clinical scientific discussions with PMDA to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc, including sponsor regulatory inspections.
Technical competencies
・Ability to provide strategic and scientific clinical research input across NPI and EG projects.
・Ability to deliver clinical programs within clinical research setting, on time, within budget and in compliance to SOPs and regulations.
・Ability to play the clinical role in a team to deliver critical milestones.
・Ability to build collaborative relationships with key internal and external partners and stakeholders
At Johnson Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at https://www.jnj.com/.
POSITION SUMMARY:
This position is accountable for leading or contributing to the development of clinical evidence generation and dissemination strategies across assigned projects.
Essential / Principal duties and responsibilities:
List the major responsibilities and duties of this position.
1)Contribute to evidence generation strategy with collaboration relationships with all cross-functional partners (e.g. Marketing, Medical Affairs, Regulatory Affairs, HEMA, etc) as a clinical member.
2)Drive assigned clinical projects leading to delivery of clinical project commitments (delivery on time, within budget and in compliance with regulations and SOP) å
3)Contribute to build team’s interface and collaboration with key opinion leaders, investigators, IRB’s/ECs, regulatory agencies, societies, associations, etc;
4)Contribute to clinical scientific discussions with PMDA to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc, including sponsor regulatory inspections.
Technical competencies
・Ability to provide strategic and scientific clinical research input across NPI and EG projects.
・Ability to deliver clinical programs within clinical research setting, on time, within budget and in compliance to SOPs and regulations.
・Ability to play the clinical role in a team to deliver critical milestones.
・Ability to build collaborative relationships with key internal and external partners and stakeholders
At Johnson Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at https://www.jnj.com/.
Experience / Skills:
・B.S. or equivalent.
・臨床試験のリーダーシップマネージメントを含む、最低3年以上の関連する科学的/技術的経験がある
・日本で治験の実施と承認取得の達成につながる1つ以上の開発プログラムでのリーダーシップ
・PMDAとの化学的な協議ができるスキル
・英語と日本語の両方で書面でのコミュニケーションがとれる
・プロジェクトの計画と管理のスキル
・影響力を発揮する能力を含む、影響力、交渉、対立解決スキルを発揮
・ときに上司の助言を得ながら、創造的な解決策を立案できるような優れた問題解決スキル
Experience / Skills:
・B.S. or equivalent.
・臨床試験のリーダーシップマネージメントを含む、最低3年以上の関連する科学的/技術的経験がある
・日本で治験の実施と承認取得の達成につながる1つ以上の開発プログラムでのリーダーシップ
・PMDAとの化学的な協議ができるスキル
・英語と日本語の両方で書面でのコミュニケーションがとれる
・プロジェクトの計画と管理のスキル
・影響力を発揮する能力を含む、影響力、交渉、対立解決スキルを発揮
・ときに上司の助言を得ながら、創造的な解決策を立案できるような優れた問題解決スキル