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clinical research 관련 취업정보

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채용공고 75+건
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    • 모두 보기: BeiGene 취업정보 - 서울 지역 채용공고 - 서울지역 Operations Associate 취업
    • 급여 조회: Medical Affairs Operation Associate Manager, South Korea
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Job Post Details

Medical Affairs Operation Associate Manager, South Korea - job post

BeiGene
별점 3.6/5점
서울
정규직
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채용 상세 정보

채용공고 유형

  • 정규직

지역

서울

상세 직무 내용

About us
BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeOne, please visit
www.beigene.com
and follow us on
LinkedIn
and
X
(formerly known as Twitter).
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
Job Description:
General Description:
This position is responsible for coordinating Medical Affairs activities and operations to secure efficiency and compliance to internal/external policies. This position will also be responsible for special projects for Korea Medical Affairs Department by leading process development and operation activities.
Essential Functions of the job:
Routine responsibilities will include:
PRAP, CUP (Pre-reimbursement Access Program, Compassionate Use Program, equivalent of CU and EAP)
  • Develop Local PRAP, CUP project plan in line with Global EAP team.
  • Support the development of local essential documents including Protocol, ICF and Patient Information etc.
  • Lead and implement the start-up activities for local this program in collaboration with local medical responsible person (including site selection, IRB submission, contracting and IP shipment).
  • Deliver the outcome of the program through the effective program and site management (except site monitoring or any on-site activities).
  • Prepare the submission of final report to MFDS with local medical responsible person and RA team.
  • In case of single patient use request, lead the whole process according to local regulation in collaboration with medical responsible person.
  • Collaborate with local medical team, PV, RA, SCM and relevant global team.
PMS (Post Marketing Surveillance or Other Phase IV study as part of RMP activity)
  • Provide the operational input for PMS project planning based on local regulation.
  • Support the development of PMS protocol synopsis and / or protocol in collaboration with local medical responsible person.
  • Participate the vendor selection process, lead and finalize the QA process and contracting for selected vendor.
  • Oversight the CRO activities as a single point of contact at BeiGene and ensure that CRO can deliver the contracted KPIs (eg. Enrollment and PMS report etc).
  • Ensure the PMS budget is managed well including scope changes.
  • Collaborate with local medical team, PV, RA, and global sourcing manger / QA / relevant teams.
This position will also serve as a special project leader that will support various Medical Affairs Functions, which
may include but not limited to:
  • Lead department initiatives, including, but not limited to new business strategy solutions, or other department initiatives, assigned by Country Medical Director.
  • Manage and Support Medical Budget allocation and expenditure under the supervision of Country Medical Director
  • Manage vendor selection (eg. GCP vendor or other important vendor for medical project) process and stakeholder management, track project budget, deliverables, and timeline, follow up on action items, archive project reports and deliverables.
  • Manage Sharepoint and archive documentation, including archiving all project documents, invoice documentation, final reports, dashboard (if applicable).
  • Support as a liaison for the contractual, payment and regulatory issue of Investigator Initiated Trial (IIT) operation with global/local medical responsible person.
  • Troubleshoot sourcing and project issues as they arise and work to bring to timely resolution.
  • Medical administrative support (e.g. vendor registration, contract approval request, SAP processing and KRPIA reporting, etc.) when necessary.
Qualification Required:
Education/Experience Required:
  • R.N or equivalent with significant experience in healthcare industry with strong clinical and medical, research background is essential.
  • Minimum 7 years or more of clinical/ pharmaceutical industry experience.
  • Knowledge of relevant regulatory and compliance requirements.
  • Strong organizational and communication skills.
Computer Skills: Excellent Microsoft office(Excel, PowerPoint, Word)
Other Qualifications: Not applicable
Travel: Extensive Local, Regional and International
What We Offer To Our Valued Employees
  • Market competitive compensation package including performance-based annual bonus scheme
  • Company shares (generous welcome grant and performance-based annual equity plan!)
  • In-house and external learning and development opportunities
  • Fantastic benefits program and keep improving!
  • Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.
  • Join us and Make momentum in your career!
BeOne Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
  • Fosters Teamwork
  • Provides and Solicits Honest and Actionable Feedback
  • Self-Awareness
  • Acts Inclusively
  • Demonstrates Initiative
  • Entrepreneurial Mindset
  • Continuous Learning
  • Embraces Change
  • Results-Oriented
  • Analytical Thinking/Data Analysis
  • Financial Excellence
  • Communicates with Clarity
BeOne is committed to respect and protect personal information rights of job applicants and will process job applicants’ personal information in accordance with applicable laws and regulations.
Due to BeOne’s global operation, job applicants’ data will be stored in Workday (currently located in the U.S.). Besides, job applicants’ data will be kept for one year to facilitate potential application for other suitable positions in BeOne. For further details, please refer to BeOne’s Job Applicant Privacy Policy (
https://www.beigene.com/privacy-policy
).
If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms.
If you have any concern, please DO NOT provide any resume or other personal information to us.
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