MSD Medical Project Specialist Studies 

Vietnam, Ho Chi Minh City 

45263134

Job Description

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
• Prepare IRB and Health Authority study submission dossier (initial submission to close-out) and application
• 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).

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 compliant
• Generate start-up plan to ensure PLPA Programs can be initiated according to planned timeline
• Generate start-up plan to ensure PLPA Programs can be initiated according to planned timeline
• Plan and evaluate PLPA Program timeline, fair market value, budget and all resource required
• Obtain approval of import license from local Health Authority
• Manage third party or vendor to execute PLPA Programs, if needed
• Negotiate contracts and budget with hospitals and vendors
• Work with Regional/Global Drug Supplies Lead to plan/arrange/manage drug supply on time
• Conduct AE/PQC reconciliation process with GPV team to align with Global Pharmacovigilance Policy/SOP

REQUIREMENTS:

• Degree or Master’s Degree in pharmacy or related health care or scientific discipline.
• At least 3-5 years of Clinical Research Associate (CRA) or monitoring experience, or project management experience or related equivalence
• At least 3 years of experience in pharmaceutical industry or other relevant experience.
• Strong project management skills and sense of urgency
• Have ability to deal with ambiguity
• Clinical study execution related knowledge, including but not limited to GCP, GPP, IRB submission, TFDA submission, site initiation/close out, site management, liaise with vendors, budget planning/management, study drug import, specimen export, etc.
• Demonstrate ethics and integrity
• Drive result, focus on customers and patients
• Act with courage and candor
• A good teamwork player with responsible working attitude
• Good communication and interpersonal skills
• Good problem-solving skills
• Knowledge Required:
• Clear understanding of our Corporate Policy/Procedure, local regulation,
• Planning, prioritization, and organizational skills
• Interpersonal & negotiation skills
• Strong attention to detail
• Understanding of project management methodologies

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.