Job Description

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 compliantEnsure studies design & implementation aligned with company Policy/SOPs/ERs/Job Aids and local regulationWork with study lead to generate budget allocation and executive plan, study timeline plan and perform Fair Market Value evaluation, and all resource required assessmentEnsure 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 LDGManage 3rd party vendor/vendor to execute LDGs and Post Approval Studies/ResearchesConduct Denied Parties Screening (DPS) Anti-Bribery/Corruption (ABC) checks for participating investigator and study personal and dean of hospitalGenerate site feasibility questionnaire and conduct site feasibility visit to enroll qualified sitesGenerate start-up plan to ensure study can be initiated according to planned timelinePrepare IRB and Health Authority study submission dossier (initial submission to close-out) and applicationNegotiate contracts and budget with investigators, hospitals, and 3rd party vendor/vendorGenerate training materials and provide training to site personnel when neededConduct 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 compliantEnsure 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 regulationConduct Denied Parties Screening (DPS) Anti-Bribery/Corruption (ABC) checks for the sponsor-investigatorEnsure Fair Market Value (FMV) assessment is completed as appropriateNegotiate contracts, budget, and payment milestone with the institution/sponsor-investigatorWork with SLRM (Scientific Leadership & Research Manager) to plan/arrange study supply and material allocation and delivery and issue paymentSend out quarterly Status Update Report request to SLRMEnsure ISP database is updated and maintained throughout the study phaseEnsure AE/SAE is reporting successfully by the sponsor-investigatorProvide 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 compliantGenerate start-up plan to ensure PLPA Programs can be initiated according to planned timelineGenerate start-up plan to ensure PLPA Programs can be initiated according to planned timelinePlan and evaluate PLPA Program timeline, fair market value, budget and all resource requiredObtain approval of import license from local Health AuthorityManage third party or vendor to execute PLPA Programs, if neededNegotiate contracts and budget with hospitals and vendorsWork with Regional/Global Drug Supplies Lead to plan/arrange/manage drug supply on timeConduct AE/PQC reconciliation process with GPV team to align with Global Pharmacovigilance Policy/SOP

F. Execute Good Documentation Practice through out for all studies, Events & activities and PLPA programs.

G. Involve or/and conduct internal audit, inspections, and other quality assurance activities.

H. Provide recommendation for continuous improvement, risk management control and knowledge transfer of Medical Scientific Affairs Projects within the company.

I. Support to Medical Scientific Affaires Operational excellence.

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 equivalenceAt least 3 years of experience in pharmaceutical industry or other relevant experience.Strong project management skills and sense of urgencyHave ability to deal with ambiguityClinical 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 integrityDrive result, focus on customers and patientsAct with courage and candorA good teamwork player with responsible working attitudeGood communication and interpersonal skillsGood problem-solving skillsKnowledge Required:Clear understanding of our Corporate Policy/Procedure, local regulation,Planning, prioritization, and organizational skillsInterpersonal & negotiation skillsStrong attention to detailUnderstanding of project management methodologies

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

12/31/2024

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

Requisition ID:R291252