Every great story has a new beginning, and yours starts here. Welcome to Warner Bros. Discovery… the stuff dreams are made of. Who We Are… When we say, “the stuff dreams are made of,” we’re not
( 概要 ) 日本国内で治験を実施するためのオペレーションチームリーダーとして,国内外のステークホルダーとの協議•交渉など,エキスパートとしてのコミュニケーションを通じ,品質を確保した臨床試験を計画通りに遂行する。 ( 具体的な業務例 ) •試験実施施設の選定戦略,症例組み入れプラン•戦略の作成及び実行 •試験遂行のための現場の責任者としてモニターへの指示及びモニターへの助言 •試験全体の進捗および GCP , SOP に沿った臨床試験の実施と品質の確保 •国際共同試験の場合,海外担当者からの指示の正確な把握及び協議を含めた円滑なコミュニケーション •試験における Risk & Issue Management •治験契約締結交渉,データ固定, GCP • SOP に基づくモニタリングに対するモニターへのフォロー •チームビルディング,ステークホルダーマネジメントによるチーム作り •社内の改善活動 / Task force team への参加 •試験全体の予算の管理 Position Summary: The
Accountability Regulatory affairs specialist is responsible for ensuring the regulatory affair of veterinary medical products and assist a product management/promotion in marketing team. Responsibilities as a regulatory affairs specialist, assist in obtaining and maintaining government approval for a veterinary medical product for
* The Associate Director of Project Management leads a team of Project Managers for Rare Disease and Neuroscience Drug Development Studies on behalf of Global Bio-tech sponsors. * ICCC services, Protocol and Regulatory Submission Consultation. Client Details * Global Contract
Position Summary: The TA Functional Manager(FM) is accountable for strategic and operational management and successful country execution of all phases of clinical trials within assigned therapeutic area(s) or specific role(s), including resource allocation, adherence to timelines and
Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and
Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich
At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your
Are you an experienced medical professional and passionate about Medical Affairs? Are you a dynamic leader with a passion for driving MSL team? If so, we have an exciting opportunity for you to join our team as
Key Responsibilities: • Execute action related regulatory compliance by having preventive and avoidance action doing risk analysis and management in RA part. • Take action to inquiry and/or instruction from Health Authority as a representative from Business
