- 이미지뷰 -
[외국계 안과 전문 기업] 임상개발 & Medical affairs HEAD
Head of Clinical Development & Medical Affairs
4대보험, 연차, 주5일근무, 중식비
- Develop and execute medical strategies in partnership with Heads of franchise and RA, and in alignment with Regional Medical Affairs (RMA)and Clinical & Regulatory Affairs (C&RA) and commercial strategies
- Build and lead MSL teams in the country and ensure appropriate deployment of the MSL teams in support of medical product strategy and pre and post-product launch preparation.
- Support the objectives of GMA/RMA through strategic leadership of the medical associates. Seen as credible medical expert by internal and external customers.
- Actively ensure scientific and strategic input into the Clinical Development Plan and strategic portfolio management within RMA through relevant participation on the Protocol Review Committee and others as appointed by RMA Leadership.
- Review and approve relevant promotional materials, activities and processes from medical affairs perspective, based on corporate compliance policies and local authority regulations
- Provide strategic and tactical guidance for medical affairs functions within the country by ensuring strategic alignment of all Medical Affairs and Clinical Development Projects performed there in relation with the global/regional strategy.
- Ensure optimal safety and clinical overview is provided by associates in all activities in scope within GMA/RMA, as relevant.
- Develop and maintain relationships with KOLs and investigators in clinical studies together with MSLs and Clinical functions in a collaborative and transparent manner.
- Provide medical resources in the active collaboration with Marketing and other commercial functions, as appropriate per SOPs, Ethics and Compliance Guidelines and local country laws to ensure integration of all medical affairs activities within the country in order to drive efficiency.
- Responsible for ensuring country adherence to PRC and other approval processes.
- Coordinate successful development of external contacts across Franchises (KOLs, influencers, key external customers investigators, academic and regulatory community), and collaborate with other C&RA local colleagues to meet customer needs.
- Ensure dissemination of trial-generated medical information within GMA to educate key influencers, including scientific and regulatory leaders.
- Responsible for resource planning and management (FTEs and phase IV budget) across Franchises within medical affairs and MSL functions.
- Membership in RMA Leadership Team
[Ideal Background (State the preferred education and experience level)]
- Education (Minimum/Preferred): MD or other relevant professional degree required, with minimum 6 years experience in pharma or medical device industry
- Languages: Fluency in both written and spoken Korean and English
- Experience (Minimum/Preferred):
∙ Knowledge of medical affairs, clinical research in product development and post-approval research
∙ Knowledge and experience of medical and scientific methodology
∙ Tactical Medical oversight for protocol development, including investigator initiated studies and coordination of registries
∙ Publication management and scientific writing
∙ Medical/scientific expertise in review/approval of content of documents for medical accuracy
∙ Demonstrable knowledge of health authority and local regulations to ensure full adherence to compliance requirements
∙ Strong interpersonal skills and the capacity to interact with variety of individuals, KOLs, payors, investigators, health authorities, etc
∙ Expertise in working in a multidimensional matrix environment and ability to manage multidisciplinary/functional medical affairs teams
∙ Ability to provide Medical opinion on product safety and ability to use within geographic market
∙ Ensure execution of medical affairs plan including post market research , medical education, research grants and scientific communication of medical plan
∙ Serve as manager of MSL(s)
∙ Excellent written and verbal communication skills, as evidenced by publications and public speaking ability.
∙ Must possess a strong sense of integrity and proven understanding record of compliance standards
1차: 서류전형 2차: 면접전형
온라인 이력서, 지원자 자유이력서 양식
[135-090] 서울 강남구 삼성동 154-8번지 C&H 빌딩 6층
최종수정일 : 2019년 08월 29일
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제휴 및 광고문의
설립일 : 2015년 12월 02일 l 개인정보책임자 : 윤병호
사업자등록번호 : 372-23-00108
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