( 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
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
Description Kenvue is currently recruiting for: Quality Supervisor This position reports into Q&C CQ Product Quality Manager and is based at Chiyoda, Japan. Who We Are At Kenvue, we realize the extraordinary power of everyday care. Built
At Johnson & Johnson, we believe health is everything. 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
Position Summary : Lead Engineering and C&Q (Commissioning and Qualification) Team at Fuji Site in alignment with/and implementing global guidelines , in following areas: - Engineering and Project Management, - Commissioning and Qualification plan and execution,
Description Kenvue is currently recruiting for Senior Manager Procurement, based out of Tokyo Japan. Who We AreAt Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science,
職務概要 Position Summary: Ø 正しい手順で時間通りに検査,製造する作業のオペレーション業務をリードし,正しい品質の製品を継続的に製造する。 Execute operations of inspection/production lines complying with the proper procedures on a timely manner and produce good quality products continuously Ø 法規制の順守に関する責任 Regulatory Compliance Responsibilities: Ø 全ての従業員はコンプライアンスの順守を最優先に行う。 All employees must concern
At Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and
Job Description Job Functions: Transform and own an outstanding supply chain experience for our customers and help improve the efficiency of our overall supply chain including crafting and driving new initiatives related to inventory, demand forecasts,
Job Description At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life – to enable our customers to make the
Job Description Division Specific Information Clinical Trials Division (CTD) partners with pharmaceutical and biotech customers around the world to ensure the right patients get the right therapies in the right doses at the right time –
Job Description When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of
Job Description Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer.
Job Description Position : Field Service Manager Location : Tokyo Here at Thermo Fisher Scientific, our industry-leading scale means unparalleled commercial reach, unique customer access, and a global footprint. Our broad customer base, from research, and clinical
Job Description Job Title: Systems Administrator Reporting to Manager, PSG IT Location: 1-12-10 Shinkiba, Koto-ku, Tokyo 136-0082, Tokyo, Japan Division Specific Information: PSG CTD Tokyo Position Summary You will contribute as a member of the PSG IT
Job Description Job Title: PPI (Practical Process Improvement) Manager (Country PPI Leader) Requisition ID: When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation.
To achieve the business plan: •Operates and manages smooth and cost-effective operations related to Visions warehouse operation and domestic transportation •Lead vendor management and develop the effective 3PL model •Monitor KPI/SLA and work with team/vendors to
Founded in 1982, MaloneBailey, LLP is a full-service, PCAOB-registered public accounting firm headquartered in Houston and with offices in Beijing, Shenzhen and Tokyo. MaloneBailey, LLP provides audit, tax and consulting services to public and private companies
