Job Description

臨床開発プロジェクトの以下の業務の実行又はサポート

• 臨床開発戦略策定
  • 早期開発戦略及び承認申請までの製剤開発を含む臨床薬理開発領域の戦略の考案
• 開発戦略に基づいた臨床薬理領域のPMDA相談資料の作成及び照会事項に対する回答作成
• 臨床薬理試験に関する以下の業務
  • 治験実施計画書の作成
  • 同意説明文書（案）の作成
  • 治験実施計画書に関連する資料（症例報告書、関連手順書等）の作成、サポート及びレビュー
  • 治験に必要な資料及び資材の準備やベンダー（国内外）との交渉
  • 治験データのメディカルレビュー
  • 治験総括報告書の作成（関係部署と協働）
• 承認申請に関する以下の業務
  • 承認申請資料（CTD）の臨床薬理パートの作成

承認申請後の臨床薬理に関する照会事項に対する回答作成

臨床薬理開発経験 5年以上

Current 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:

Temporary (Fixed Term)

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

05/13/2025

*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.