◈ 직무 개요

* Review and approve domestic/global product development plans

- Review and approve product licensing strategies by country
- Review and approve strategies for product differentiation
- Review and approve product entry plans by country
- Approve the development plan according to the characteristics of PK/PD by product
- Review and approve clinical development plan (development stage, development period, cost, etc.)
- Supervise product license strategies progress
- Supervise product entry plans by country
- Supervise all tasks for investigational new drug application (document preparation, response to regulatory agencies, briefing session)
- Supervise all tasks for Clinical Trial (Clinical Milestone, IP, CRO, IRB)
- Supervise all tasks for new drug application (clinical study report, response to regulatory agencies)
- Supervise all tasks for Post Marketing Surveillance (PMS Milestone, CRO, CRF, budget, QC, protocol, report, etc.)
- Manage organization (manpower, budget, CP, work process, training)

◈ 경력 요건

- 신약/신제품 개발 임상기획 경험자
- 전주기 임상시험 운영 경력 및 최소 10년의 책임있는 프로젝트 관리 경험

- 의학, 약학, 간호학, 수의학 학사 또는 이와 동등한 학위 이상
- 영어 능통자 및 다국가 허가 임상 유경험자 

  

◈ 처우

- Negotiable 

◈ 제출 기한

- ASAP

◈ 제출 서류 및 기타

- 국문이력서 

◈ 담당 컨설턴트

- 김현주 / 02-2016-6645 / jadekim@vpeople.co.kr