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 atJob Function
Regulatory Affairs Group
Job Sub Function
Regulatory Affairs
Job Category
Professional
All Job Posting Locations:
Chiyoda, Tokyo, Japan
Job Description
目的と役割
Johnson & Johnson MedTechはOrthopaedics, Surgery, Electrophysiology, Neurovascularなど、複数の事業領域を展開しています。今回の募集では、Orthopaedics領域での薬事担当を想定したポジションです。該当するbusiness unitのRA managerにレポートします。
主な義務と責任
会社の事業戦略と整合させるように必要となる薬事のアクションを企画、準備し、実行することでビジネスの目標達成を支援する。
新製品導入等の担当プロジェクトに関する薬事戦略を構築し、海外製造元などの関係者に働きかけてサポートを得ながら、薬事申請を実行する。また、PMDAなどの審査機関や行政組織と交渉・連携し、迅速かつ確実に承認取得を達成する。
上市後の変更管理手続き等、製品を安定的に市場に供給し続けるため、あるいは、供給を終了するにあたり、関連法規制及び社内規定に従って関係者と連携し必要となる社内プロセス及び薬事に関する手続きを完遂する。
その他の義務と責任
社内規定に基づく広告審査業務及び海外製造元を含む社内関係者からの依頼や問い合わせへの対応
部門の優先課題など、組織的projectや活動への参加と貢献による価値創造
ビジネスの健全な成長と自社のreputationを維持、向上するために有効なコンプライアンス関連業務(主として薬機法)
必要な経験、スキル及びコンピテンシー
少なくとも5年以上の医療機器(クラスII以上)の薬事業務経験を有する。又はこれと同等と判断できるだけの経験を有する。
海外製造元の作成した設計開発文書(英語)を読解、理解することができ、また海外の社内関係者と口頭及び文章でコミュニケーションし、自らプロジェクトを推進することができる程度の英語力を有する。
あれば歓迎する経験、スキル及びコンピテンシー
PMDA対面助言(医療機器開発前相談、非臨床試験の医療機器プロトコル相談・評価相談や医療機器臨床試験要否相談等)を担当としてリードしたことがある。
薬事業務全般について、自身で完遂できるだけでなく、他者やチームメンバーのサポート・支援経験。
修士以上の学位(工学、理学、農学、薬学、医学、歯学、生命科学・公衆衛生学等)
・If you are Japan employee, please read "Internal Application Guideline" in Ask GS. Especially if you are less than 18 months in your current role, you are required to obtain application approval from your current manager as well as your respective BUHR. If you are Japan's employee, you are not able to apply for multiple positions at once.
・Once you move to 1st interview stage, please make sure to inform to your current manager.
・For Employee Referral Program (ERP), please read and understand the details of "Employee Referral Program" in Ask GS and make a compliant referral.
・応募の際はAskGS内の社内公募ガイドラインをご一読いただき、応募ください。18か月未満の方は応募前に上長及び担当BUHRの許可を取ってから応募ください。複数同時応募不可になります。
・在籍期間に関わらず、書類選考を通して1次面接に進んだ場合は、社内公募に応募し選考に進むことを上司に報告してください。
・社内紹介を行う場合は、ASK GS上の"Employee Referral Program"の詳細を理解した上で、コンプライアンスを守って紹介したものとみなします。
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes.
The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.
Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans.
In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.
ジョンソン・エンド・ジョンソンは、当社の整形外科事業を分離・独立(セパレーション)し、DePuy Synthesとして独立した企業を設立する計画を発表しました。セパレーションは、必要な諸条件が満たされることを前提に、18〜24ヶ月以内に完了する見込みです。これに伴い、本ポジションはセパレーション完了後にDePuy Synthesの従業員として雇用されることになり、DePuy Synthesの雇用体系、プログラム、ポリシー、福利厚生が適用されます。詳細につきましては、適切なタイミングでDePuy Synthesより通知される予定です。Required Skills
Preferred Skills:
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