募集要項
・グローバル医薬品開発・市販後の品質マネジメント基盤構築・信頼性保証業務(主に下記業務)
・SOPマネジメント体制及び業務の維持・管理、標準化推進・支援
・GxP、規制等の教育・トレーニング体制及び業務の基盤構築・推進
・GxPベンダー品質マネジメント(含むQualification)
必要な経験・スキル
・製薬企業又はCROで品質マネジメント/品質管理業務
・GCPの知識(ICH-GCPや国内外規制)を有し、臨床試験のプロセス全般に精通している。
・品質マネジメント(ISO9000シリーズ等)の基礎的な知識
・柔軟な思考とチームで協業可能なコミュニケーション力と調整力
・クロスファンクショナルな活動場面で課題解決をリードまたはファシリテート可能なスキル
・グローバルチーム・環境での業務経験
・英語でのコミュニケーション能力(リモートを含む会議での議論・意見交換、メール、資料作成、プレゼンテーションが可能、目安としてTOEIC700点以上)
以下の業務経験等があれば尚可
・海外他社との協業経験、社内グローバルチームでの業務経験
・プロジェクトリーダー、チームマネジメント、チームビルディングの経験
・臨床開発関連業務経験(臨床モニター、安全性報告業務等)
・SOPマネジメント業務、トレーニングマネジメント業務、GxPベンダー品質マネジメント業務
・ICHガイダンス全般、各国の規制(主に臨床開発関連)の知識
資格・身分
・上記経験とスキルがあれば特になし
・上記経験とスキルがあれば特になし
給与
経験・能力を考慮し、当社規定により算出します。
昇給・賞与
昇給:年1回 賞与:年2回(7月、12月)
福利厚生
各種社会保険、社宅制度、財産形成支援制度、自己啓発支援 等
休暇
年次有給休暇、リフレッシュ休暇、育児休業制度、介護休業制度、ボランティア休暇 等
諸手当
住宅手当、通勤手当、出張・外勤手当、時間外労働手当等
休日
毎週土曜日・日曜日、祝日、会社設定休日(GW・夏季・年末年始)等
勤務地
東京(品川区) ※第一三共グループは2020年4月より敷地内全面禁煙です。また標準就業時間帯は、事業場内外を問わず禁煙となります。
募集人数
若干名
備考
入社時期:応相談
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・高校からの学歴・職務経歴を記載ください。
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Word,Excel,PowerPointもご利用いただけますが
使用するPC環境によりレイアウトが変わる可能性がありますので、
PDFファイルのアップロードをお勧めいたします。
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