Job Description

業務内容：

グローバル戦略に沿った、効率的かつ付加価値の高い新薬等の国内開発薬事戦略の構築 規制当局（厚生労働省、独立行政法人医薬品医療機器 総合機構など）との窓口業務 承認申請・審査資料、機構相談資料、照会事項に対する回答等へのレビュー・アドバイスを通じ、当局提出文書の質の向上に資する 承認申請・審査資料、機構相談資料、照会事項に対する回答等の作成・提出のコーディネーション 新薬承認申請に関する薬事情報の収集・分析、関係者への提供／共有 当局対応（30日調査、対面助言、申請準備、審査対応）の際の、米国本社も含めた社内調整（スケジュール管理）

必須条件：

＜経歴・経験＞

製薬系会社又は医薬品開発に関する勤務経験承認申請・審査対応の経験ライフサイエンス系大学院卒以上

＜知識・スキル＞

薬学あるいは医学に関する基本的知識英語文献読解、国外担当者とメールでのコミュニケーションができるレベルの英語力コミュニケーションスキル　

望ましい条件、資質：

＜思考・行動＞

前向き論理的思考主体・行動型

＜知識・スキル＞

薬機法等薬事規制に関する知識

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

Job Description

Develop an efficient and high value-added Japan regulatory development strategy in line with global strategies Responsible as a contact parson with regulatory authorities (MHLW and PMDA, etc.) Contribute to improving documents quality submitted by authorities through review on CTD, PMDA consultation documents, responses to inquiries, etc. Coordination of preparation and submission of NDA, PMDA consultation, responses to inquiries, etc. Collection and analysis of regulatory information on NDA etc. and sharing to relevant parties Coordination including HQ when interacting authorities (30-days review, PMDA consultation, NDA submission, NDA review)

Required Qualifications

Experience working at a pharmaceutical company or company related to pharmaceutical developmentFiling/Review experiencesMaster of Life Sciences or above

Basic knowledge about pharmacy or medicineEnglish skill at a level capable of reading English literature and communicating by email with overseasCommunication skills

Desired Qualifications

PositiveLogical thinkingInitiative / action type

Knowledge of Pharmaceutical Affairs Regulations

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:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:12/31/2024

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.

Requisition ID:R277303