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Title:  Manager Medical Affairs

Location: 

Seoul, KR, KR

Global Business Unit:  HEC
Job Function:  Regulatory Services
Requisition Number:  164905
Description: 

RESPONSIBILITY

  1. Develop and establish strong scientific peer to peer engagement with top tier Key External Experts (KEE) & KOL for the product/disease area responsible, through providing latest scientific medical data to KEEs/KOL to enhance their understanding of the disease/s and the scientific value of our products that address the unmet medical needs of the disease.
  2. Provide expert medical input into key Government Affairs and Market Access activities
  3. Coordinate the development and execution of Medical Brand Plans, with identified and

 

 

agreed KPIs, to support Brand objectives

  1. Respond to off-label or complex Medical Information queries in accordance with reg ional/ local SOP, referencing to global standard responses
  2. Reviewing and approving proposed fair market value honorarium for services by HCPs with local CSR.
  3. Responsible in reviewing and approving promotional and non-promotional materials according to the local code/regulation and internal guidance, to ensure the balance, integrity and accuracy of the information produced.
  4. Leverage medical insight from internal and external customers into local evidence generation plans to support the development of Brand value propositions for the market
  5. Ensure medical support for pharmacovigilance activities, execution of Risk Mitigation Activities for all products (NEBU)
  6. Timely upload medical articles/videos/journals and Accurate use of the contents in Dr. KyowaKirin & submitting monthly report, progress check.
  7. Input into a development of local protocols, patient information leaflets (including sign-off of risk/benefit statement) and named patient programs.
  8. Take personal ownership of own training (e.g. IDP) & development to be fully compliant with the designated training plan held on TEAMS & ZOOM Learning and to maintain the high level of knowledge required to operate in the role.
  9. Develop and maintain KOL (key opinion leader) and medical expert relationships while providing customer insight through assessment of future needs of customers.
  10. Plan and organize training of pertinent medical content to internal and external partners.
  11. Review and approve promotional, scientific, and training materials as necessary.
  12. Ensure the appropriate dissemination of clinical, medical and scientific information in a timely and ethical manner including but not limited to unsolicited off-label requests and product related issues.
  13. Assist in developing novel IIS (Investigator Initiated Study) ideas and provide references.
  14. Lead key product presentations to demonstrate the benefits to thought leaders, medical groups, government agencies and health systems.
  15. Coordinate policies and procedures for development and provision of medical and technical information relating to the company's products.
  16. Proactively identify potential solutions to address internally and externally recognized needs for medical information.
  17. Budget estimation, managing KKKR MA internally

 

 

  1. Vendor selection for Phase 4 trials of NEBU, HOBU and NTABU

 

 

QUALIFICATION

  1. Thorough knowledge or experience of the pharmaceutical industry and the Medical Affairs function
  2. Ability to interact and manage a range of stakeholders both internally and externally
  3. Knowledge of legislation relevant to pharmaceutical sales and marketing
  4. Bachelor's degrees in relevant subject required.
  5. 3+ years combined experience in pharmaceutical industry, academic research, or healthcare management.
  6. Management experience in Global Medical Affairs or related field preferred (Work experien ce in Rare Disease and Hemato-Oncology is an advantage)
  7. Demonstrated understanding of legal, compliance, and regulatory guidelines related to the conduct of a variety of types of research trials in the pharmaceutical industry.
  8. Experience working in a global organization - preferred
  9. Experience working in a matrixed environment – preferred
  10. Good in English and mother tongue language skills
  11. Excellent Project, Excel, PowerPoint and Word document development experience
  12. Strategic networking and good interpersonal communication skills across all levels of the organization
  13. Highly detail-oriented with excellent follow-up skills
  14. Team player and collaborative
  15. Capability to work and problem solve independently, but in complete alignment wit h KKC,KKAP and other affiliates colleagues
  16. Personal accountability, self-motivation with high degree of initiative
  17. Integrity, Collaboration(Wa), Innovation and Commit to life
Requisition Number:  164905
Job Function:  Regulatory Services

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