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GSK

薬事オペレーション部長

GSK is hiring a 薬事オペレーション部長 for a remote role open to applicants in Japan. Level rates it ; you can apply on GSK.

Level's read on this job

  • On Level's scale, this role is Little AI ●○○○: aI is not part of the work.
  • This is listed as a remote role.
  • The posting mentions regulatory affairs, drug development and project management among its tools and skills.
  • GSK has 949 other open roles on Level.
  • Posted within the past two weeks.

AI in this role

Head of Regulatory Operations at GSK managing submissions, global document systems, and a team of specialists in Japan.

regulatory-affairsdrug-developmentproject-managementteam-leadershipdocument-management

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.

How we rate this

薬事オペレーション部長 at GSK rates 0 out of 100 for how much of the daily work is AI. That makes it Little AI (AI Level 1 of 4). The level is about AI in the job, not seniority.

Classification

Little AI. AI is not part of the work.

  1. ●●●● Builds AI80 to 100
  2. ●●●○ Works on AI60 to 79
  3. ●●○○ Uses AI40 to 59
  4. ●○○○ Little AI0 to 39

Levels come from how often the tools, models and workflows of the role are named in the posting itself. Read the description and count the AI tools, models and workflows it names.

Prepare for this job

Built from this posting and from similar jobs on Level.

Skills and AI tools this role asks for

Regulatory AffairsDrug DevelopmentProject ManagementTeam LeadershipDocument Management

Questions you could be asked

  1. Tell me about a project where regulatory affairs was part of your work. What did you do?
  2. Tell me about a project where drug development was part of your work. What did you do?
  3. Tell me about a project where project management was part of your work. What did you do?
  4. Tell me about a project where team leadership was part of your work. What did you do?
  5. Tell me about a project where document management was part of your work. What did you do?

Adapt your resume

  • List these exact terms on your resume: Regulatory Affairs, Drug Development, Project Management, Team Leadership, and Document Management. An applicant tracking system matches the wording, not the idea.
  • Attach one line of real, concrete experience to at least one of them. A tool named with nothing behind it rarely survives a human read.

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