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CMO Office, Clinical Lead (Manager)

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大手外資系医療機器メーカー  臨床開発ポジション

募集要項

業務内容

This position is accountable for all scientific discussion/deliverables, especially in case of the necessity of some clinical data, study design and outlines, study results and clinical data package in clinical studies (included company initiated studies (CIS) and Post Marketing Surveillance (PMS)) in the assigned projects, from early to post-marketing. This position is responsible to discuss the clinical data package and/or the necessity of clinical data, to execute designing, implementation and completion of clinical studies fulfilling clinical data package for appropriate submission and also to execute appropriate communication with Pharmaceuticals and Medical Devices Agency (PMDA) about clinical studies; e.g. PMDA consultation, submission, etc

And accountable to ensure input and support in the development of Evidence Generation strategy as representative from Clinical Research.

1)Responsible for team’s interface and collaboration with Key Opinion Leaders (KOLs) and management.
2)Lead clinical scientific discussions with PMDA, including proposed clinical investigations.
3)Lead the confirmation for clinical data, study results, and essential documents for the clinical data package, and lead the regulatory inspection by PMDA
4)Develop, revise and maintain study design and outlines, scientific rationale, Protocol Synopsis and full protocol of the local clinical studies/CIS/PMS.
5)Lead to implement study protocol including knowledge transfer to clinical operation team, execution of clinical study oversight of clinical studies/CIS/PMS in Japan, and also to prepare for the following documents as applicable:
・Investigator’s Brochure (IB) – Japanese translated version
・Case Report Form (CRF)
・FAQ on patient eligibility or other medical issues and potential concerns
・Major protocol deviation criteria, if any
・Safety management plan, if any
・Statistical Analysis Plan (SAP)
・Analytical risk based monitoring plan
・Related other documents to clinical studies
・Training materials for clinical operation team involved and investigators
6)Lead to execute medical monitoring while conducting independent clinical study in Japan (Local study).
7)Lead to develop Clinical Study Report (CSR) of the Local study, relevant parts of Summary of Technical Documents (STED), including discussion on appropriate data interpretation from top line results and tabulations, and key message clarification.
8)Lead to develop annual report of PMS and report to Health Authority
9)Lead to develop publication plan with collaborative relationships with Medical Affairs.
10)Lead to file relevant parts of STED as JNDA including labeling discussion.
11)Contribute to package insert (J-labelling) development.
12)Develop and maintain working relationships with others requiring interaction and mutual support
13)Contribute the development and deliver appropriate Evidence Generation strategy to support New Product Development and Life Cycle management with collaborative relationships with all cross-functional partners (e.g. Marketing, Medical Affairs, Regulatory Affairs. HEMA, etc).

語学力


・日本語(ネイティブもしくはバイリンガル)
・英語(reading、writing、speaking、TOEIC800以上、若しくは同等)

給与

年俸制
賞与 年2回
当社社内規定準じる

メディカルカンパニ― 年3回支給(6月・12月・翌3月に分割支給)

雇用形態

正社員

勤務地

東京都

通勤交通費

全額支給

休日

年間休日122日
【休日】
土日祝日、会社規定

【休暇】
年末年始休暇、慶弔休暇、有給休暇

休暇メモ】
有給休暇は7/1に付与

福利厚生

各種社会保険完備

通勤手当 営業手当健康保険 厚生年金 雇用保険 労災保険
企業年金・財形貯蓄 持株会 利子補給制度 ホームヘルパー制度

自己啓発支援:
・費用全額を会社が負担する、選択性の社外研修プログラム
・英会話学校の半額費用を会社が負担するプログラム

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この求人に応募

企業情報

事業内容

■総合医療・健康関連用品の輸入・製造販売

世界最大級のヘルスケアカンパニーとして、消費者向け製品、医療機器、医薬品の分野で数万アイテムに上る製品を、世界中のお客様に提供している企業です。

業種分類

メーカー/日用品
メディカル/医薬品メーカー
メディカル/医療機器メーカー

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  • 北海道・東北
  • 関東
  • 上信越・北陸
  • 東海
  • 関西
  • 中国
  • 四国
  • 九州・沖縄
  • 海外
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