Medical Project Specialist

**POSITION OVERVIEW**:
Plan, initiate, conduct and manage global/regional/local medical & scientific affairs studies (including Local Data Generation (LDG), HECON, Post Approval Studies/Researches, Investigator Studies Program (ISP) and In Scope Research Types (interventional or non-interventional)), and Pre-License Patient Access Programs (PLPA) in compliance with regulations and company SOPs and Policy under the supervision of manager.

**PRIMARY ACTIVITIES**:
**1. Study related**:
**A. Implement a series of local/regional/global planned LDGs, HECON, and Post Approval Studies/Researches with customers, under the supervision of manager**:

- Work closely with internal (study lead, Pharmacovigilance, Legal, Compliance, Finance and Sourcing and Procurement Lead) & external stakeholders (Scientific Leaders, Health Care Provider, hospital official/administrative, vendor, 3rd party vendor, etc.) to implement and track the studies timely with quality, within budget and compliant
- Ensure studies design & implementation aligned with company Policy/SOPs/ERs/Job Aids and local regulation
- Work with study lead to generate budget allocation and executive plan, study timeline plan and perform Fair Market Value evaluation, and all resource required assessment
- Ensure NIS LDGs database (such as Value Evidence Activity Portfolio (VEAP), Real World Evidence Operations (REV/OPS)) is updated and maintained throughout the study phase.
- Ensure all study related documents are archived into Veeva Vault MedComms (VVMC).
- Work with Sourcing and Procurement Lead to complete the supplier Qualification (Information Technology (IT) risk assessment, Privacy Assessments, Anti-Bribery & Corruption due diligence (ABC), Denied Party Screening (DPS), etc.) and Due Diligence and Selection Questionnaire processes for vendors engaged in LDG
- Manage 3rd party vendor/vendor to execute LDGs and Post Approval Studies/Researches
- Conduct Denied Parties Screening (DPS) Anti-Bribery/Corruption (ABC) checks for participating investigator and study personal and dean of hospital
- Generate site feasibility questionnaire and conduct site feasibility visit to enroll qualified sites
- Generate start-up plan to ensure study can be initiated according to planned timeline
- Negotiate contracts and budget with investigators, hospitals, and 3rd party vendor/vendor
- Generate training materials and provide training to site personnel when needed
- Conduct AE/PQC reconciliation process with GPV team to align with Global Pharmacovigilance SOPs /ERs/Job Aids and local regulation.

**B. Implement a series of Investigator Studies Program (ISP) and In Scope Research Types (interventional or non-interventional) with customers, under the supervision of manager**:

- Work closely with internal (Scientific Leadership & Research Manager, Medical Advisors/Medical Scientific Liaison, Pharmacovigilance, Legal, Compliance) and the institution/sponsor-investigator to implement and track the ISPs timely with quality, within budget and compliant
- Ensure Investigator Studies Program (ISP) and In Scope Research Types (interventional or non-interventional) design & implementation aligned with company Policy/SOPs/ERs/Job Aids and local regulation
- Conduct Denied Parties Screening (DPS) Anti-Bribery/Corruption (ABC) checks for the sponsor-investigator
- Ensure Fair Market Value (FMV) assessment is completed as appropriate
- Negotiate contracts, budget, and payment milestone with the institution/sponsor-investigator
- Work with SLRM (Scientific Leadership & Research Manager) to plan/arrange study supply and material allocation and delivery and issue payment
- Send out quarterly Status Update Report request to SLRM
- Ensure ISP database is updated and maintained throughout the study phase
- Ensure AE/SAE is reporting successfully by the sponsor-investigator
- Provide professional guidance and suggestion to investigators who conduct Investigator Studies Program (ISP) and In Scope Research Types (interventional or non-interventional).

**C. Timely track the publication status of studies (submission time, acceptance/rejection, conference, journal). Publication includes conference poster, abstract, oral presentation and manuscript published in peer-reviewed journal.**

**D. Execute all study related administrative tasks, such as execute contracting and study payment, arrange study material allocation and delivery, arrange SIV/PI meetings, budget management and monthly accrual, etc.**

**E. Implement and track Owned PreLicense Patient Access Programs (PLPA) and ensure the execution quality, under the supervision of manager**:

- Work with Therapeutic area Medical leads, MSLs, Pharmacovigilance, Regulatory affair & Clinical Safety (GRACS) Country Lead and Market Access, Regional Drug Supplies Lead and Supplies Chain Management Lead, Legal and Compliance, Finance & Procurement, DPOC and External vendors implement and track the Owned PLPA Programs timely with quality, within budget and