Abbott
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
Primary Job Function
- Manages and coordinates all activities related to clinical research and medical affair for both Abbott investigational and marketed products
- Handle medical inquiries and review promotional materials on Abbott EPD (established pharmaceutical division) products in accordance with Abbott policies (Global/Local) & procedures, and local laws/regulations
Core Job Responsibilities
- Manage the planning and execution of clinical studies including BE(Bioequivalence) studies, PMS(Post Marketing Surveillance) and IIS(Investigator Initiated Studies) in accordance with Abbott’s policies/procedures and local regulations.
- Handle medical inquiries in the form of verbal communication or written responses.
- Review Promotional materials in accordance with the applicable laws and requirements
- Train relevant function regarding MIS
- Manage Promotional and Scientific material review and approval system (SPECTRA)
Position Accountability / Scope
- Position accountability/Scope for CR
- Ensure all clinical activities including PMS are performed according to corporate, ethical and legal requirements
- Manage internal review and approval of all clinical activities as required by SOP
- Provide the required oversight to manage review, approval and conduct of IIS studies.
- Prepare periodic/final reports on clinical activities as required by SOP or local regulations.
- Position accountability/Scope Medical affairs
- Provide medical & scientific input for commercial strategic plans including pipeline
- Review and approve that promotional material follows the applicable laws and requirements, contains appropriate, state of the art and scientifically correct information to support appropriate use of its products.
- Search for medical information on Abbott EPD products and provide comprehensive/balanced information to customers (e.g. healthcare professionals and consumers) for handling medical inquiries
- Provide training or advice for relevant function to understand and comply with the applicable laws, regulations and Abbott policies
- Manage and communicate with Global regarding SPECTRA as a representative in Korea and train the users
- Check and ensure procedures of Affiliate Medical Information Service reflect latest global procedures and local regulations.
- Engage KOLs to get scientific advice through Advisory Board Meeting or other non promotional medical projects
Minimum Experience/Knowledge Required
- Scientific related degree or equivalent qualification
- Experience in pharmaceutical company is required for minimum 8 years, CR/MIS/PMS related experience is preferred
- Pharmacist is preferred
- Understanding of local regulation regarding CR/MIS/PMS
- Familiarity of medical terminology and product information
- Good communication skills with internal and external stakeholders
- Good written and spoken English capabilities
To apply for this job please visit www.jobs.abbott.