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  3. 外資医療機器メーカー:Medical Scientific Affairs Sr. Specialist / Specialistの求人情報詳細

Medical Scientific Affairs Sr. Specialist / Specialist

外資医療機器メーカー

  • 外資系企業

想定年収

600万円 ~ 900万円

勤務地

東京都

仕事内容

This role is responsible for collecting and reporting clinical data necessary for product development in Japan, as a CRA and as an assistant to the manager, based on SOP and related regulations.

Specifically, this role will include the following

・Execute the clinical development activities in line with international and local requirements.
・Ensure basic understanding of project scope, milestones, and time codes and strive for high quality, timely, and efficient delivery.
・Act as direct contact with assigned clinical sites, use judgment to assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites.
・Participate in Investigator and other external or internal meetings as required.
・Perform on-site visits in accordance with the monitoring plan; apply judgment and knowledge to independently resolve site issues, questions and concerns.
・Manage and process documents in accordance with company policy.
・Attend audits/regulatory inspection if requested.
・Maintain a positive, results oriented work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced, and objective manner.
・Maintain a working knowledge of, and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, SOPs, other training requirements, and study specific procedures and training.
・Support the global MSA activities in Japan and provide regular status updates to MSA Manager in written and oral format

募集人数

1人

応募条件

技能/経験

・Bachelor’s degree in Medical Science, Public Health, Natural Science (Biology, Chemistry etc.) or Healthcare Professionals or Biostatistics is an advantage.
・Minimum 7 years' experience in conducting clinical study. Medical device’s experience is an advantage.
・Experience in the international clinical study based on ISO14155.
・Excellent written English communication skills are required; strong verbal English communication skills are an advantage.
Frequency of Overnight Business Travel:
Start-up phase: Approximately 50% of the week / Thereafter: At least twice per month.

・Competency in medical and scientific writing is an advantage.
・Clinical knowledge or experience in neurosurgery, interventional radiology, and/or Orthopaedic surgery is an advantage.


・Excellent Interpersonal Skills: effective communication and the ability to build and maintain relationships with internal/external stakeholders.
・Firm and Tactful: Balances assertiveness and diplomacy, handling difficult situations and conversations with professionalism, tact, and sensitivity.
Flexibility: Adapts to changing circumstances and priorities. Shows resilience and flexibility in the face of challenges and ambiguity.
・Ethical and Professional: Upholds high ethical standards and maintains confidentiality. Demonstrates professionalism and integrity in all interactions and decision-making.
・Even with a complex organizational structure and reporting lines, able to gain the trust of surrounding stakeholders by maintaining appropriate levels and quality of communication.
・Person with high motivation / spirit of challenge at work: Able to proactively identify necessary resources and request support to effectively carry out tasks.

学歴

大学

職務経験

(7年以上)

業界経験

年齢

年齢制限不問  

英語力

初級以上

その他語学力

語学力詳細

勤務条件

雇用形態

無期雇用

試用期間

有り(3ヶ月)

給与

年俸制

年収:600万円 ~ 900万円

月額基本給:35万円~53万円

賞与・インセンティブ

年3回  昨年実績:うち固定賞与年2回

・会社業績連動賞与あり
※ご年収は前職給与を考慮し、ご経験・スキル・能力により決定。
※詳細はオファーレターにて記載いたします。

昇給

有り 年1回
※詳細はオファーレターにて記載いたします。

勤務地

東京都

就業時間

09:00~17:30

休憩時間:12:00~13:00

残業:月10時間~20時間程度

残業手当

通常の残業代

通勤手当

交通費:全額支給(実費支給)

休日・休暇

完全週休二日制, 土, 日, 祝日, 年末年始

年間休日:123

年間有給休暇:有給休暇は入社後3ヶ月目から付与されます
( 初年度 10日 3か月目から )
【休日・休暇詳細】
年次有給休暇、慶弔特別休暇

社会保険

雇用保険, 健康保険, 労災保険, 厚生年金

求人No.:NJB2401540

最終更新日:2026/8/3

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  3. 外資医療機器メーカー:Medical Scientific Affairs Sr. Specialist / Specialistの求人情報詳細