日系の大手医薬品メーカー｜Global Compliance and Planning Manager｜法務・パラリーガル・弁理士・知的財産の転職・求人情報なら「法務求人.jp」

Global Compliance and Planning Manager

【具体的には】
The Global Compliance and Planning Manager will:
－Lead Global SOP/Work Instruction (WI) WG, ensuring a defined set of global and/or regional/ local SOPs are in place as part of the SOP roadmap. Ensure there are optimised processes for gap analysis, governance, and implementation of priority 1, 2 and 3 SOPs/WIs. The role will involve working across Sub-functions globally within GRA, and with stakeholders outside of GRA.
－Global Risk Register WG, ensuring processes are in place that support the Global Risk Register WG’s implementation of regulatory risk identification, tracking and mitigation steps to allow for greater optimisation, metrics development and reporting to management. The role will involve implementing an optimised communication plan to allow for relevant risks are shared with appropriate stakeholders.
－Lead the cultivation of a framework for Compliance and Planning metrics development and execution. Activities also include development of framework for Compliance and Planning Sub-function collaboration with other Sub-functions in reporting the status of GRA metrics to GRSC. Further this role will support the provision of strategic advice on implementation of mitigation strategies.
－Ensure implementation and maintenance of other Compliance and Planning initiatives, such as training matrices and inspection readiness within a region. Related to inspections, activities may include attendance, preparation and follow up on inspections/audits on a regional and global basis.

◆従事すべき業務の変更の範囲は下記のとおりです。
会社内での全ての業務を命じることがある。

【必要な業務スキル、経験】
Position Requirements
■Education
ーBachelor's degree (science discipline preferred). Further relevant qualification desirable.
ーAt least seven or more years’ experience in the pharmaceutical industry, with approximately 4 years that includes working knowledge of compliance activities within Regulatory affairs and Quality.
■Technical Skills
ーDetail oriented.
ーProject management skills.
ーAbility to understand regulatory and technical concepts and requirements.
ーUp-to-date knowledge of both existing and emerging regulatory guidance and sciences related to labelling or compliance and planning.
ーGood working knowledge of Microsoft Office required.
ーPrior experience with assessing change controls.
■Physical Requirements:
ーOffice environment.
ーPosition requires approximately 10% domestic and international travel.

【求める人材像】
Key Competencies specific to the role
ーCultural sensitivity is essential and the ability to develop consensus within a multinational organisation necessary.
ーBroad level of interpersonal skills, leadership ability and flexibility also necessary.
ーExcellent collaboration skills needed.
ーExcellent problem-solving skills also needed.
ーExcellent written and oral communication skills needed.

【語学要件】
Language skill:
ーProfessional English Proficiency
ーJapanese language skills are preferred

正社員

契約期間：応相談

東京都千代田区

636万円 ～ 1260万円

屋内禁煙

【必須項目】非喫煙者

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