Sr. Medical Affairs Specialist

Job Description

Responsible for the end-to-end process of executing Observational or non-interventional research studies in compliance with Good Pharmacoepidemiology Practice (GPP) and required Procedural Documents with a team of specialists, which includes planning, initiating, executing on, and closing out of primary data collection, chart review, database, and molecular epidemiology studies

Is mainly responsible for managing portfolio of study projects with the team, which includes:

• Participate in providing strategic input to all countries/ clusters in LATAM Data Gap Analysis activities, and provide meeting minutes and management of future LDGs projects prioritized in these meetings

• Manages the end‐to‐end process of executing observational or non‐interventional research studies in compliance with Good Pharmacoepidemiology Practice (GPP) and required procedural documents which includes planning, initiating, executing on, and closing out of the following: primary data collection, chart review, database, and molecular epidemiology studies.

• Ensures poster and publication development, including formatting, medical writing, figure/data content development, coauthor review, internal review process, and journal submissions.

• Manage study‐level budget, which includes tracking invoices/spend, navigating financial systems, using business programs, as applicable, and communicating with stakeholders, including Finance and the Budget Management organization.

• Utilizes, manages, and maintains document repositories and internal/external systems (e.g., REV/OPS, Veeva Vault).

• Provides operational support for applicable fair market value assessments, Anti‐Bribery and Corruption (ABC), and due diligence checks, site contract and budget review/approval, informed consent, study registration, IT and/or privacy assessments, vendor qualification, transparency reporting, adverse event reporting and reconciliation, and publication submissions.

• Supports development of training/ educational initiatives related to publications/ scientific methodology trainings to LATAM V&I GMSA Therapeutic area teams.

• Manages the end‐to‐end process for executing ISPs in compliance with required procedural documents and applicable local regulations.

• Develop reports, metrics related to Research Management & Health Systems LATAM area.

• Reviews requests for information/proposals, drafts scope of work, and facilitates the execution of appropriate service, confidentiality, and consultant agreements and subsequent amendments/change orders

• Provides supplier oversight to ensure alignment with all SOPs and other internal/external requirements

• CoLeads internal/external meetings and drafts/reviews agenda/minutes

• Tracks timelines/deliverables and follows up on action items

• Helps manage study-level budget, which includes tracking invoices/spend, and communicating with stakeholders, including Finance and the Budget Management organization

• Liaises with outsourced suppliers and cross-functional teams to communicate and oversee project status and/or needs

• Participates in protocol and interim/final report preparation and approval

• Coordinates the review and finalization of all supplier documents such as the safety management, data management, communication, project management, and validation plans

• Participates in quality control assessments and ensures integrity of study data for reports and publications

• Understands, coordinates, and documents adherence to internal, external, and regulatory compliance requirements

• Collaborates extensively and troubleshoots issues by providing potential resolutions, with internal and external partners to ensure timely management and execution of studies

• Utilizes, manages, and maintains document repositories and internal/external systems (e.g., REV/OPS, Veeva Vault, Ienvision, etc)

• Provides operational support for applicable fair market value assessments, ABC, and due diligence checks, site contract and budget review/approval, informed consent, study registration, IT and/or privacy assessments, vendor qualification, transparency reporting, adverse event reporting and reconciliation, and publication submissions

• Ensures poster and publication development, including formatting, medical writing, figure/data content development, co-author review, internal review process, and journal submissions

Required Qualifications & Experience

• Healthcare Professionals with 3+ years of relevant experience in clinical research & guidelines. Desirable Specialization in epidemiology, project management or public health.

• Fluency in English (written and verbal)

• Experience in Study Management, including site performance and patient recruitment

• Understanding in the procurement process and sourcing capabilities

• High level of familiarity with a broad range of compliance areas and ability to assess risk and develop solutions

• Awareness of digital innovation

• Computer literacy, particularly with Microsoft applications

Skills

• Ability to effectively prioritize and manage multiple projects simultaneously, work strategically and collaboratively across departments.

• Demonstrated experience in identifying process gaps and building new processes

• Demonstrated ability to innovate with practical solutions for complex issues

• Ability to lead, organize, coordinate, and execute on multiple concurrent and complex projects

• Proactively contributes to a positive team attitude and highly productive teamwork environment

• Excellent interpersonal, negotiation, communication, and presentation skills

• Strong personal integrity and high ethical standards

• Close attention to detail and high level of accuracy

• Effective, versatile, and action-oriented approach

• Strong business and financial acumen and a customer focus

• Demonstrated strong decision-making skills and ability to weigh advantages, disadvantages, and business impact for rapid decisions

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Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
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:

Project Temps (Fixed Term)

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

na

Required Skills:

Advisory Board Development, Clinical Trial Planning, Continuing Medical Education (CME), Data Analysis, Medical Knowledge, Medical Marketing Strategy, Medical Policy Development, Medical Training, Multiple Therapeutic Areas, Pharmaceutical Medical Affairs, Pharmacovigilance, Scientific Communications, Stakeholder Engagement, Strategic Thinking

Preferred Skills:

Job Posting End Date:

08/29/2025

• 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:R362118