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説明
Job Title
Clinical Science ManagerJob Description
Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.
But it's not just what we do, it's who we are. We are 80,000, wonderfully unique individuals, with two things in common. An unwavering sense of purpose and a relentless determination to deliver on our customers' needs. It's what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.
The world and our customers' needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That's why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.
In this role, you have the opportunity to make life better
Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So whatever your role, if you share our passion for helping others, you'll be working towards creating a better and fairer future for all.
あなたには、プレイングマネージャーとして臨床(クリニカル)のあるクラスIVの薬事申請実務、およびチームマネジメントをご担当いただきます。
業務内容
・製造販売承認/認証申請、届出(計画立案、資料取集、PMDA/NB 照会対応)
・承認/認証の維持管理業務(変更管理、定期更新)
・QMS適合性調査申請
・保険収載業務(保険適用希望書作成等)
当社は『治療』領域に参入し、今後もビジネス拡大を推し進めています。企業を買収し、担当製品も年々増えてきています。
まだまだ会社のノウハウも少ないため、ご自身の経験を活かし、自分なりにスキームを構築していける、自由度の高い環境です。
経験/スキル(必須)
・薬事申請(クラスIII以上)での実務経験
・医薬品医療機器等法(承認申請、QMS、保険)に関する基本的な知識
※ピープルマネジメント経験不問
経験/スキル(歓迎)
・厚生労働省、PMDA側での薬事申請対応経験
・生物学、工学PhD
語学
日本語:母国語レベル(もしくは、読み書き含め、極めて流暢な方)
英語:ビジネスでの使用経験のある方 ※英語での面接も実施予定
募集要項
【契約期間】期間の定めなし
【試用期間】試用期間あり(原則として入社日より6ヶ月)
【就業場所】品川オフィス
【就業時間】9:00-17:30 休憩時間:原則として12:00-13:00
【休日】毎週土曜日(所定休日)、日曜日(法定休日)、国民の祝日、年末年始(12月29日-1月4日)
【休暇】有給休暇:初年度最大20日間(入社月により変動)、CareLeave(年間10日間)、Sick Leave(年間最大30日間)ほか
【時間外労働】あり 月20~30時間相当
※ただし、管理職での採用の場合は、残業代は支給対象外(深夜勤務手当、休日深夜勤務手当の支給はあり)
【給与】基本給(月)65万円~123万円
【賞与】インセンティブ (年1回支給)
※インセンティブ は、毎年3月支給。ただし、会社業績、部門業績、個人評価によって変動して支給されます
※年度途中入社者は対象期間中日割計算あり
【加入保険】社会保険(厚生年金保険、健康保険)・労働保険(雇用保険、労災保険)
【所属社名】株式会社フィリップス・ジャパン
How we work at Philips
Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles.
Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.
Why should you join Philips?
Working at Philips is more than a job. It's a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.
