Job Description 職務内容 クリニカルリサーチ領域での開発品の本邦臨床開発に係る以下の業務を担当する グローバル開発戦略における本邦臨床開発計画の立案・作成 本邦で実施する治験の科学的側面からのリード 臨床開発に係るPMDA相談準備・資料の作成 実施計画書の立案・作成（米国本社等、ステークホルダーへの説明・交渉を含む） ローカル試験：試験骨子から作成 グローバル試験：日本で実施するために計画書を適性化 他の治験関連資料（同意説明文書案、症例報告書、関連手順書等）の作成（他部門と協働） 治験実施のサポート（オペレーション部門と協働） 治験データのメディカルモニタリング 治験総括報告書の作成（メディカルライターと協働） 承認審査における臨床関連パートのリード 承認申請資料（CTD）臨床関連パートの作成（メディカルライターと協働） 臨床関連照会事項に対する回答作成 治験に関する学会発表及び／又は論文作成・サポート 必要とする資質 以下の業務を含む、製薬企業における臨床開発経験（５年以上） 臨床試験の運用経験（グローバル試験、ローカル試験、アジアン試験等） 臨床試験関連資料の作成・レビュー経験（治験実施計画書、同意説明文書等） 医学、薬学、公衆衛生学又は生命科学に関する学位（6年制学士又は修士以上） 未経験分野にチャレンジするフロンティア精神とリーダーシップ 国内外のチームメンバー及び社内外のステークホルダーと密接に協働するためのソフトスキル TOEICスコア730点以上に相当する英語力 Current Employees apply HERE Current Contingent Workers apply HERE Secondary
When our values align, theres no limit to what we can achieve. At Parexel, we all share the same goal - to improve the worlds health. From clinical trials to regulatory, consulting, and market access, every clinical development
■ 職務内容 / Job Description Monitor is responsible to ensure that the trial is conducted and documented properly by carrying out the following activities when relevant and necessary to the trial and the trial site in
Job Title CT Clinical Scientist Job Description Job title: CT Clinical Scientist Key Areas of Responsibility 1.Identify and connect new customer needs, solutions and technologies to initiate new methods (or disruptive enabling technologies) of diagnosis, treatment and/or care
Job Overview Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Project Lead is an essential member of the core
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
Are you interested in improving the lives of millions of people, contributing to a company that works with innovation and is a pioneer in addressing the unmet medical needs? Do you have an innovative mindset to
Job Description The position takes a responsibility for medical contents in all clinical development programs in assigned therapeutic areas (such as dementia, movement disorders, neuromuscular, and MS/Immunology etc.) in Japan. The individual functions as a scientific and
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.
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 - enabling our customers to make the world
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 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 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,
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 - enabling our customers to make the world
Job Description Outbound managerとしてチームのリードをお任せします。倉庫オペレーション業務経験のある方、治験ビジネスにご興味のある方、将来的にキャリアを広げる方向性に興味のある方、英語を使った仕事に挑戦したい方など、ご応募をお待ち申し上げます。 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 Technical Services Manager (Japan) 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
Job Description 1. About Thermo Fisher Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue of approximately$40 billion. Our Mission is to enable our customers to make the world
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our
Title: Medical Advisor / Medical Scientific Liaison FOP Company: IPSEN K.K. Job Description: As part of the Medical Affairs department, the MA/MSL is a hybrid, field-based scientific expert to external and internal stakeholders delivering non-promotional information
Job Purpose: MSL Manager is accountable for leading and driving performance of MSL department in corresponding therapeutic area. MSL Manager drives MSL department by setting the right business objectives and priorities aligned with global counterpart to
