ABOUT US: Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomeds Patients First! culture drives our
職種 正社員 職務明細 Role of Sales Operations is to support the effective and efficient functioning of a companys sales department. Its main responsibilities include formulating sales strategies and KPIs, driving sales and marketing initiatives, supporting monitoring
Our clients Microsoft Business Solutions team is a Microsoft Gold Partner and leader in Microsoft software implementations for medium to large organisations, providing their clients with the ability to keep up with the ever-changing digital world
Company Description Jobs for Humanity is collaborating with FIS Global to build an inclusive and just employment ecosystem. We support individuals coming from all walks of life. Company Name: FIS Global Job Description Position Type :
Company Description 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
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 several
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 several
About KnowBe4 KnowBe4, the provider of the worlds largest security awareness training and simulated phishing platform, is used by tens of thousands of organizations around the globe. KnowBe4 enables organizations to manage the ongoing problem of
Job Purpose: クローバルメディカルライティング及び国内マトリックスチームと協働し、規制当局に提出する承認申請資料、臨床試験の関連文書等の作成をリードする。関連法規、ガイドライン及び社内規定に従い、戦略的に、正確で科学的な文書を遅滞なく作成し、臨床試験の実施及び承認申請・取得に貢献する。また、効率的な文書作成プロセスを推進する。 Key Accountabilities/Responsibilities: 規制当局に提出する薬事文書の作成のリード:CTDの臨床・臨床薬理パート、対面助言資料、照会事項回答等 臨床試験に関連する文書の作成:治験実施計画書、治験総括報告書等 上記文書の作成におけるストラテジー・key messageの作成、文書作成のファシリテート、解析計画等の検討、スケジュールの作成及びCROマネジメント等 Basic Qualification: Skill CTD臨床パート、治験総括報告書、治験実施計画書等、承認申請や臨床試験に関連する文書の作成能力 社内外の関係者と円滑にコミュニケーションし、マトリックスチームをリードすることができる Global Medical Writing と協業するための英語でのコミュニケーションスキル ロジカルシンキング ダイナミックな変化のある状況下において、柔軟性・自発性をもって問題解決能力を発揮し、目標に向かって推進できる能力 臨床試験に関する基本的知識 生物統計学、薬物動態学に関する基本的知識 薬事規制、ICHガイドライン等に関する基本的知識 基本的なPCスキル(Word、Excel、PDF) Experience 製薬企業又はCROにおけるメディカルライティング業務経験(3年以上) Preferred Qualification: Skill 英文メディカルライティングスキル(治験総括報告書、治験実施計画書等) Experience 承認申請及び審査対応業務の経験(CTD作成、照会事項対応) 臨床開発業務又はそれに準ずる業務経験 複数部署の関係者で構成されるチームをリードした経験 Education/Certification/Language 薬学部または理学系学部卒以上 理学系修士または同等のもの。MD、PhD、PharmD(必須ではない) 職務内容および勤務地の変更範囲は会社の定めるところとする。
Job purpose Medical Science Liaison (MSL) is a field-based role in the new Medical and Development organization, reporting to MSL Head. In order to build a trust with External Experts (EE) and scientific community through, MSL needs to
Company Description Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative
HOTEL DESCRIPTION Kagoshima is the southwestern prefecture of the Kyushu Island. Major economic pillars of the prefecture include agricultural and food, electronic and automotive-related industries. The Hotel will be part of a mixed-use development that comprises
About BHP: At BHP we support our people to grow, learn, develop their skills and reach their potential. With a global portfolio of operations, we offer a diverse and inclusive environment with extraordinary career opportunities. Our
Job Description: Head of Marketing - Oracle Netsuite (Japan) Position Overview: As the Head of Marketing for Oracle Netsuite in Japan, you will play a pivotal role in shaping and executing our marketing strategies to drive
Do you enjoy working as an Executive assistant to the C-level office? Are you interested in utilizing both Japanese and English at a global company? About our Team Elsevier Health applies innovation, facilitates insights, and helps
Job Profile SummaryJob Overview Responsible for management and service delivery excellence for assigned projects, covering single or multiple Lifecycle Safety functions (clinical trial and / or post-market). Provide leadership and accountability for customer-facing activities and oversight
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
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
Job Summary Initiating the Environmental, Safety, and Health programs and policies in our organization, ensuring compliance with local regulation, and keep no TRR. In this Role, Your Responsibilities Will Be Developing and implementing ESH strategies, procedures
The Medical Director, Clinical Pathologist/Laboratory Medicine provides medical consultative and interpretive support to Labcorp biopharma solutions and its internal and external customers. The Medical Director is responsible for medical decision-making and consultation related to laboratory services and clinical trials. Duties