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 endtoend process of executing observational or noninterventional 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 studylevel 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 AntiBribery 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 endtoend 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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