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 at
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 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
Johnson & Johnson is recruiting for a TS ASPAC SD/Logistics J&J internal consultant leader in Japan to be the technical lead for the upcoming SAP S/4 Hana Transformation initiative from 2023. This Supply Chain Digitalization program
The Associate Director of Medical Affairs, Multiple Myeloma (MM) Medical Science Liaison (MSL) will be responsible for organizational operation and people management of the MM MSL group, reporting to the Director of Hematology, Medical Affairs Japan. A strong insight
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
Responsibilities: l Manage the implementation of capability initiatives and quality control of final deliverables. l Drive the needs assessments, capability program design, delivery, measurement and embedding with a strong focus on external engagement excellence. l Ensure
Job purpose: Responsible for implementing the Medical Affairs Plan of specified Team strategies, driving a consistent approach to carrying out scientific engagement activities internally and in the field; ensuring compliance with all relevant regulations and GSK policy/code
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 at
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 at
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 at
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 at
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
This is what you will do: The Medical Affairs Associate Medical Lead prepares a medical plan, which serves as the basis of medical activities of Alexion Pharma GK (AP-J) as a whole, and carries it out in cooperation with MSL
Are you interested in improving the lives of millions of people, contributing to a company that works with innovation and is a pioneer in antidiabetic drug? If yes, this position of Senior Medical Advisor for diabetes is
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
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 SUMMARY The HR Manager directs and works with Human Resources and Operations employees to carry out the daily activities of the Human Resource Office including oversight of recruitment, total compensation, training and development, association/labor relations,
Join us today and make a difference in peoples lives! ・Prepare and provide effective training programs both for LivaNova CP sales team and customers ・Assess the findings through the scientific/clinical study and support Marketing team how
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
