Medical Project Lead

[Duties] 
The primary duties of the Medical Project Lead are to be the operational lead for governance of local evidence generation activities (e.g. post-authorization safety studies as part of Risk Management Plan, other locally generated IS/NIS SITs, and local investigator-sponsored studies) and Managed Access Programs, and also work as the lead function for Patient Support Programs.

[Job Information]

• Line Reporting : Head of Medical & Patient Affairs
• Work Location : Seoul

[Responsibilities]

 i. Non-interventional, Post Authorisation Safety Study (PASS)

The Medical Project Lead is a Local Responsible Person for PASS (LPASS) when MFDS requires a PASS or a comparable local study as part of risk management plan (RMP) activity for new drugs.  Main roles of the MI & EG Officer are:

• To communicate with MFDS as the point of contact regarding PASS-related matters, including study preparation and execution, covering supplementary requests such as protocol amendments, sample size adjustments and other interactions as necessary.
• To prepare PASS protocol, CRF to be validated by LPV, LRA and HO and submits it to MFDS at least one (1) month before the expected launch of the concerned product. The Medical Project Lead is an Initiator in worldwide medical affairs evidence generation platform (eg. iENVISION) where the concerned program is created and the relevant documents are uploaded.
• To prepare and submit Periodic Reports and Final Study Report to MFDS in collaboration with LPV, LRA and HO.
• To select CRO through relevant bidding process and prepare contract and manage the CRO throughout the project
• To check that the relevant documents are archived and stored as required by the relevant regulations.

ii. Local Evidence Generation (Interventional, Non-interventional, SUD SIT & ISS)

The Medical Project Lead is in charge of local evidence generation studies operation, including but not limited to company-initiated studies such as observational study using real-world or secondary use of data (SUD), interventional study, and governance role for local investigator-sponsored studies (ISS). Main roles of the Medical Project Lead are:

• To engage in the communication with the medical affairs point of contact in planning, initiating, conducting and completing phase of study.
• To maintain a strong knowledge of the study concept or protocol to answer questions from internal stakeholders in the review committee meeting in terms of study governance.
• To manage local evidence generation studies to ensure deliverables are met within the established timelines, budget and quality/compliance
• To manage interface with CROs in cooperation with outsourcing management and line functions; ensure vendors meet quality standards; contribute to the development/amendment of vendor contracts; Case Report Forms (CRFs), data review reports and trial statistical analysis plan in collaboration with CRO and forecast budget with accuracy.
• To be the governance body for local ISS for regular checkup and abidance to local regulation and SOPs for due diligence
• To support inspection readiness and monitoring related activities and assists with internal audits and HA inspections, as required, and ensures implementation of corrective actions within specified timelines

iii. Managed Access Program (MAP)

The Medical Project Lead is responsible for managing of Managed Access Program from operational perspective based on the internally approved treatment plan. Main roles of the Medical Project Lead are:

• To be the governance body for local MAP programs in line with local regulation and global/local internal requirement
• Operational lead for MAP execution with A to Z understanding of overall process
• Be the point of contact of MFDS communication
• To keep up-to-date with the latest regulation and SOPs
• To archive MAP relevant documentation as per required process for inspection readiness

iv. PSP/PAP (Patient Support Program/Patient Access Program)

The Medical Project Lead is responsible for overseeing the new and ongoing PSP/PAPs as the governance body, providing guidance with regard to the latest regulations and SOPs.

The Medical Project Lead is also responsible for writing and reviewing local SOPs and OPMs related to above responsibilities.

Perform other related duties and special projects as assigned by Head of Medical Affairs.

[Requirements]

• Pharma industry experience dedicated to local clinical trial/study operation for at least 5 years

• Bachelor’s degree or above

• Native-level proficiency in Korean, with the ability to communicate effectively with local authorities and regulatory bodies

• Fluent in Business English, both written and verbal

• Management experience of SITs including PMS

• MAP/EAP, PSP experience a plus