外資系大手製薬メーカー【Medical】Medical Evidence Lead (Med.EL),メディカル本部 エビデンス＆オブザベーショナルリサーチ統括部

資格・要件

■ 応募資格(経験、資格等) / Qualification (Experience & Skill etc.)

【経験 / Experience】

＜必須 / Mandatory＞

Clinical research experience (> 5 years) meeting any of the following:

- Leading protocol development, data management, analysis, result-interpretation, reporting and publication

- Working in R&D and/or Medical function in pharmaceutical industry

- Working in epidemiology, public health research, clinical research, or related evidence generation fields

＜歓迎 / Nice to have＞

• •Working experience in CVRM or R&I area

• Clinical project leader/study leader experience

• Research using statistics and epidemiology

• Planning and execution of database research using personal health data

• Experience in a data science role

• Oversight of CROs/ESPs for clinical studies

【資格 / License】

＜必須 / Mandatory＞

Master's degree in a scientific discipline

＜歓迎 / Nice to have＞

PhD in a scientific discipline or MD

【能力 / Skill-set】

＜必須 / Mandatory＞

• Clinical research methods, study design, and applied methodological principles

• Project Management

• Leadership and Communication

• Medical writing

• Cross-functional stakeholder management

＜歓迎 / Nice to have＞

• Scientific Publication

• Ability to review analysis dataset and tables, figures, and listings specifications

【語学 / Language】

＜必須 / Mandatory＞

日本語 Japanese：Native or equivalent (日本語検定1級レベル)

英語 English：Practical English communication skill / TOEIC 800

＜歓迎 / Nice to have＞

Working experience outside Japan and/or in global organizations/teams

職務内容

職務内容 / Job Description

Medical Evidence Lead (Med. EL) is a project leadership role that generates valuable real-world evidence and accelerates the use of real-world data for medical evidence generation in line with brand strategy. Med. EL applies clinical research methods, methodological principles, and a strong understanding of the strategic business context in the relevant therapeutic area to enable high-quality evidence generation across study planning, execution, and reporting.

Depending on study needs and organizational assignment, Med. EL may serve in either one or both of the following leadership capacities:

• Study Lead (Operational Lead), driving cross-functional study planning, project management, operational execution, external service provider selection and oversight, and delivery throughout the study lifecycle

• Methodological Lead, driving methodological reliability and scientific robustness of study design, protocol development, analytical requirements, interpretation, and reporting Med. EL works cross-functionally with internal and external experts, including Data Scientists, Statisticians, Medical Affairs colleagues, External Service Providers (ESPs), and/or research collaborators as appropriate, to ensure that study activities and outputs are aligned with study objectives, timelines, quality standards, budget, relevant regulations, and internal procedures.

【その他情報】
契約期間：期間の定めなし
試用期間：6か月
就業時間：9:00～17:15
休憩時間：60分
フレキシブルタイム：あり
時間外労働：あり
休日休暇：
完全週休2日制（休日は土日祝日）
年間有給休暇　初年度12日
年間休日日数121日
【将来的に従事する可能性のある職務内容】会社の定める職務
＜将来的に勤務する可能性のある場所＞会社の定める事業拠点（テレワークを行う場所を含む）
■公休日：完全週休2日制(土、日)・祝日・年末年始6日
■休暇：年次有休休暇・慶弔・赴任・リフレッシュ
受動喫煙対策：あり　就業場所　全面禁煙
加入保険：雇用・労災・健康・厚生年金保険
在宅勤務制度：有