Are you passionate about implementing Health Economic Outcomes Research (HEOR) projects? Do you want to make a meaningful impact on patient lives? We are looking for a HEOR Specialist to join our Market Access team at
( 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
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied
* 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
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
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
* Manage timely product approvals for target indications in Japan * Align with global strategies and Japanese healthcare requirements * Collaborate across departments for regulatory compliance * Develop and update Japanese clinical development plans * Handle submissions
POSITION SUMMARY •Responsible for leading the MSL group activities. •Support for HCPs through timely dissemination of emerging scientific and medical information from amultitude of sources. •Analyze and identify key MSL insights, and provide to the DA
Responsible for executing the following basic MSL tasks under the guidance of his/her superior and the support of a senior MSL. • Responsible for building trust relationship with Key Individuals (KIs) in their therapeutic area and
Responsible for executing the following basic MSL tasks under the guidance of his/her superior and the support of a senior MSL. • Responsible for building trust relationship with Key Individuals (KIs) in their therapeutic area and
Responsible for executing the following basic MSL tasks under the guidance of his/her superior and the support of a senior MSL. • Responsible for building trust relationship with Key Individuals (KIs) in their therapeutic area and
ROLE SUMMARY The Platform: The Chief Medical Affairs Office’s RWE Partnerships and Platforms organization is responsible for establishing global RWE data and scientific leadership through the generation of integrated, end-to-end observational real-world evidence serving all therapeutic areas
Are you passionate about improving patient outcomes? Do you have experience in medical affairs and a desire to make a difference in the healthcare industry? We are looking for a Medical Advisor to join our dedicated team
SUMMARY Responsible and accountable for Medical Affairs strategy of Urological cancer products C ollaborates with internal and external stakeholders including key opinion leaders to develop and implement the overall M edical Affairs strategy for product lifecycle align ed
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
Take lead in diverse range of RA projects to support clients in obtaining regulatory approval. Provide expertise in RA strategy/development. Client Details * One of the largest global CROs in the industry * Partnering with small
Job Description Job Summary: To ensure that clinical supplies are stored and distributed in accordance with Fisher Clinical Services (FCS) approved procedures and policies, cGMP, cGDP, and regulatory requirements. Maintain the FCS Japan Quality System in compliance with
Job Description When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. Surrounded by collaborative colleagues, you’ll have the support and opportunities that only a global leader can give you. Our respected,
企業概要 AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples lives across
