薬事オペレーション部長

Job description

主に新薬および新ワクチンの開発および承認取得のための規制当局（PMDAおよびMHLW）への提出資料作成に関して国内およびGlobalとの連携を含むDocument作成のProject Managementを行なうJapan Submission ManagerのSupreviseおよびGlobalな薬事ドキュメントシステムの導入および運用のLeadを行う薬事オペレーション部の部長ポジション。４人の部員をSuperviseする。また薬事部門のLeadership Team Memberの一員として部門の運営の一翼も担っていただく。 ※職務内容および勤務地の変更範囲は会社の定めるところとする。/ Future scope of job and working location will be determined by company. 【必要な条件 Basic Qualification 】 ・スキル/Skill：医薬品開発業務の理解および経験、Cross Functionalに働ける能力、部下の育成力およびリーダーシップスキル、英語のコミュニケーション能力 ・経験/Experience：製薬企業における薬事業務・開発業務、ライン管理職の経験 ・学位/資格/語学力 Education/Certification/Language：大卒以上、流暢レベルの日本語力・ビジネスレベルの英語力（読み・書き・会話） ※日本での就労資格を有すること。/ Legal right to work in Japan. 【望ましい条件 Preferred Qualification】 ・スキル/Skill：Global製薬企業におけるリーダーシップスキル、薬事文書システムについての知識と理解、業務効率化 ・経験/Experience：Global製薬企業におけるMatrix組織におけるマネジメント経験、当局提出資料の作成・マネジメント経験、外部ベンダーマネジメント経験 ・学位/資格/語学力 Education/Certification/Language：同上 Skills Agile Planning, Business Acumen, Change Management, Digital Fluency, Influencing Without Authority, Learning Agility, Problem Solving, Regulatory Strategies Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. We are committed to creating an inclusive workplace and providing equal opportunities for all applicants. We embrace an agile working culture across our roles, so if flexibility is important to you please discuss opportunities with our hiring team. If you need any adjustments to the recruitment process to help you demonstrate your strengths and capabilities, contact APACRecruitment.Adjustments@gsk.com. Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.