Job Description
募集メッセージ
感染症、ワクチン領域における臨床開発プロジェクトリーダーを募集します。関連領域での臨床開発経験を有し、社内外のステークホルダーと連携してプロジェクトを前に進め、医療及び公衆衛生に貢献する意欲のある方を歓迎します。
職務内容
クリニカルリサーチ領域での開発品の本邦臨床開発に係る以下の業務を担当する
本邦での臨床開発計画の立案・作成
本邦で実施する治験の科学的側面からのリード
〇 PMDA相談資料の作成
〇 実施計画書の立案・作成(米国本社等、ステークホルダーへの説明・交渉を含む)
・ローカル試験:試験骨子から作成
・グローバル試験:日本で実施するために計画書を適性化
〇 他の治験関連資料(同意説明文書案、症例報告書、関連手順書、等)の作成サポート
〇 治験実施のサポート
〇 治験データのメディカルモニタリング
承認審査における臨床関連パートのリード
〇 承認申請資料(CTD)臨床関連パートの作成(メディカルライターと協働)
〇 臨床関連照会事項に対する回答作成
治験に関する学会発表及び/又は論文作成、あるいはそれらのサポート
必要とする資質
以下の業務を含む臨床開発経験(7-8年以上。原則、ワクチンまたは感染症領域の経験者)
臨床試験の運用経験(国際共同試験、国内試験、アジア共同試験等)
臨床試験関連資料の作成・レビュー経験(治験実施計画書、同意説明文書等)
医学、薬学、公衆衛生学又は生命科学に関する学位(6年制学士又は修士以上。博士又は公衆衛生学修士取得者は尚可)
英語力(TOEIC 800点以上または準ずる能力)
国内外のチームメンバー及び社内外のステークホルダーと密接に協働するためのソフトスキル
* R4 のグレードで採用予定です。
Required Skills:
Accountability, Clinical Study Design, Learning Sciences, Negotiation, Strategic ThinkingPreferred Skills:
Infectious Disease Research, Vaccine DevelopmentCurrent Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
06/30/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
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