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 Bei Gene 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, Power Point, Word)
Other Qualifications: Not applicable
Travel: Extensive Local, Regional and International
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