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2019년 제1차 해외제약전문가 초빙 공고
| 작성자 | 관리자 | ||
|---|---|---|---|
| 작성일 | 2019-02-15 | 조회수 | 3,328 |
| 출처 | 한국보건산업진흥원 | ||
| 원문 | |||
| 첨부파일 | |||
Consultant application form A-D.docx(26.54KB)2019년 제1차 해외제약전문가 초빙 공고
국내 제약기업의 신약개발 역량강화와 글로벌 진출 확대를 위한 기업 맞춤형 컨설팅 및 교육 등을 담당하는
분야별 진흥원 상주 해외제약전문가를 신규로 초빙하고자 다음과 같이 공고합니다.
2019년 2월
1. 공고기간 : 2019.2.18.(월) ∼ 3.28(목),6주간
2. 공고내용
○ 해외제약전문가 신규 초빙 인원 : 0명
- 국내 제약기업의 신약개발 역량강화와 글로벌 진출 확대를 위한 기업 맞춤형 컨설팅 및 교육 등을 담당하는 분야별 진흥원 상주 해외제약전문가 신규 초빙
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분야 |
세부내용 |
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R&D 기획 |
․후보물질도출, 전임상, 신약가치평가, 데이터 분석 및 해석 ․단계별 허가, 임상, 마케팅 연계 |
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임상 |
․전임상, 임상(데이터 해석, 임상시험 프로토콜 설계 등) ․신약개발을 위한 IND신청시 필요항목 점검 및 시험항목 선정 ․국제적 수준의 GCP, GLP 및 ICH 국제기준 등에 대한 컨설팅 등 |
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생산(GMP) |
․신규 제약 생산시설 건설(국내, 해외)에 대한 전반적 컨설팅 ․GMP Audit(Inspector)실무경험(EMA, FDA등, ICH 가이드라인 등) ․cGMP에 대한 소프트웨어 Validation, Documentation 등 경력자 |
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인허가(RA) |
․WHO PQ 획득 관련 컨설팅, 미국, 유럽 및 중국의 인허가 획득 전략 컨설팅 ․신약개발 및 인허가 획득을 위한 IND 및 NDA Filing, CTD 작성 관련 컨설팅 ․해당국가 허가규정 및 해외시판허가·등록에 관련된 컨설팅 |
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기술 마케팅 |
․한국 제약기업의 전략적인 해외 진출 컨설팅 ․해외 특허 취득관련 컨설팅 및 시장진출 컨설팅 ․해외 기업과 한국 기업의 파트너쉽 확립 |
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PM |
․신약 개발관련 전반적 R&D계획, 임상/전임상 인허가(RA), 마케팅 등의 컨설팅 |
※ 세부내용은 붙임의 해외제약전문가 신규 초빙 공고문(국문, 영문) 참조
3. 공고방법 : 보건산업진흥원 홈페이지, 해외지사 홈페이지, 제약산업정보포털 등 온라인 공고
4. 초빙 및 선정 절차 및 일정(안)
○ 초빙공고 → 신청서 접수(02.18∼03.28(목)) → 자격 및 서류심사(04.05(금)) → 면접심사(04.11(목)) → 선발결과 통보예정(04월 말) → 채용 (5월 이후)
KHIDI is looking for “Global Pharmaceutical Experts” who can provide training and consulting services to Korean pharmaceutical companies for new drug development and global commercialization.
1. Job Description
Global Pharmaceutical Experts share their knowledge and provide advice to Korean pharmaceutical companies as KHIDI executive consultants in the fields of pharmaceutical Research and Development (R&D) planning, clinical trial, GMP (Good Manufacturing Practice), Regulatory Affairs (RA), Technical Marketing, and Project Management (PM).
□Consulting Fields
|
Field |
Description |
|
R&D Planning |
Consultation on drug candidate selection, pre-clinical trial, pipeline valuation, data output analysis |
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Clinical Trial |
Consultation on pre-clinical and clinical trial data analysis, protocol design, etc. |
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GMP (Good Manufacturing Practice) |
Consultation on a construction of new pharmaceutical plants, GMP audit from foreign regulatory authority, software validation and documentation |
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Regulatory Affairs (RA) |
Registration and pricing of new drugs, IMDs, biosimilars and generics at multinational pharmaceutical company or FDA Consultation on WHO PQ process (ex. Work experience in USP) ※ possible to be located at the KHIDI U.S office |
|
Technical Marketing |
Consultation on global marketing strategy and practice, especially on product/technology licensing-out, alliance building and management, product registration, and business model formation. |
|
Project Management (PM) |
Consultation throughout pharmaceutical value chains which involve the entire process from drug discovery, development, clinical trial, regulatory affairs, manufacturing, and marketing |
□ Qualifications
The applicant should have at least 10 years (20 or more years preferable) of experience in the pharmaceutical industry, such as employment at multinational companies, national regulatory agencies, major consulting firms, higher educational institutions, and research organizations.
※Experts in Regulatory affair(RA), Technical Marketing or Project Management(PM) are preferred this year.
□Terms of Employment
-A Global Pharmaceutical Expert is a full-time employee of KHIDI during the period specified on the contract.
-The beginning and end dates of the employment are negotiable between an applicant and the KHIDI team.
-The minimum length of each employment is three months.
-Due to KHIDI annual budget management system, all employment contract ends in December 31st,2019;however,the contract will be renewed in the subsequent year.
□Remuneration
-Salary commensurate with work experience.
※The before-tax monthly salary ranges from KRW10.5 million (USD 9,500) ~ KRW20.5 million (USD18,500).
Personal expenses such as travel, housing, moving, etc., are not covered by KHIDI.
2. Selection Criteria and Hiring Process
□Selection Criteria
-A comprehensive assessment on the candidate’s expertise, integrity, and the job commitment will be performed based on the contents of application package and the interview result.
|
Criteria |
Qualifications |
|
Expertise (60) |
① Academic background - degrees(Bachelor, Master, Doctorate, etc.,), diplomas, relevant certificates ② Fitness to the recruiting field ③ Professional background - experience in a national regulatory agency, university, research institution, multinational/local company preferred ④ Major accomplishment in recent five years - Project, patent registration, paper publication, certification, award, etc. |
|
Integrity (20) |
① Ability to faithfully perform assigned tasks ② Willingness to perform assigned tasks |
|
Commitment (20) |
① Degree of commitment for a KHIDI Global Pharmaceutical Expert position ② Knowledge and experience in the pharmaceutical industry ③ Availability for long-term employment |
□Hiring Process
- After an applicant submits a complete application package, only the qualified applicant will be contacted to set up the time for an interview. An applicant can request a video interview if he/she is located outside of Korea.
※If material omission or misrepresentation of the applicant’s qualification is discovered, the applicant will be disqualified from the hiring process at any point.
- February 18th~March28th:Applicationpackagesubmission
April 11th:VideoInterview
~April 31st:Contractfinalizationforthequalifiedapplicant
※Schedule is subject to change. An applicant is personally notified of the result.
3. Application Package
①Cover letter (1~2 pages, It is necessary to state clearly the intent of the application.)
②Consultant Application Form A~D
③Curriculum Vitae
④Certificate(s) of degree
⑤Proof of employment
⑥Proof of payment(pay slips) from recent three months
⑦Other supporting documents
※Awards in relevant field, if applicable
※Any documents that can be used verify facts from other parts of the application package
4. How to Apply
□The complete application package must be submitted by E-mail only.
※Application deadline: 11:59 PM (Korea local time), March. 28th,2018
※Submitted documents shall not be returned and not be used for other purposes than hiring process. These documents are treated under rules and regulations by the Personal Information Protection Law in Korea.
-KHIDI (Korea): Jung, Hyunhee (yiruja21@khidi.or.kr)
□Inquiries
- Pharma & Bio-Pharma Global Team, KHIDI
KHIDI (Korea): Baek, Min Seon ☎+82-43-710-0024, E-mail : christine369@khidi.or.kr
