One of our enterprise clients who is an american multinational healthcare company that researches, develops, manufactures, and sells pharmaceuticals and medical technologies is currently seeking a
Regional Medical Affairs Operations Manager to support and optimize Medical Affairs operations across Southeast Asia. This project focuses on building, running, and continuously improving Medical Information (MI), copy review (MLR), patient safety interfaces, and performance dashboards to ensure compliant, timely, and insight-driven decision-making.
Job Description
What you'll do:
- Lead and standardize Medical Information operations, including intake, triage, response workflows, and documentation across multiple channels
- Manage and maintain a Standard Response Document (SRD) library, including version control, references, and audit-ready archives
- Support copy review / Medical-Legal-Regulatory (MLR) processes by coordinating reviews, tracking cycle times, and enforcing evidence and substantiation standards
- Interface with patient safety and quality teams to ensure proper intake, triage, and follow-through of adverse events and product complaints
- Define and track operational KPIs across MI, MLR, safety, and education programs
- Build and maintain dashboards (e.g., Power BI, Excel-based reporting) to surface insights and support monthly operating reviews
- Own or update SOPs, RACIs, and operational documentation to maintain audit readiness
- Coordinate with cross-functional stakeholders such as Regulatory, Quality, Legal/Compliance, Commercial, and Data/IT
- Support training, onboarding materials, and playbooks to drive adoption of standardized processes across markets
Qualifications
What you'll need to have:
- 5+ years of experience in Medical Affairs, Medical Information, Regulatory, Quality, or Safety within MedTech or Pharma
- Hands-on experience with MI operations, SRDs, unsolicited off-label inquiries, and evidence-based scientific communication
- Working knowledge of MLR / copy review processes and claims substantiation
- Familiarity with medical device safety or vigilance workflows, including AE and product complaint intake
- Strong data and analytics skills, including advanced Excel and experience with BI tools such as Power BI or Tableau
- Experience working across Southeast Asia markets or other multi-country regions with varying regulatory requirements
- Excellent written and verbal English communication skills; additional SEA languages are a plus
- A highly organized, compliance-minded approach with strong stakeholder management and process-improvement skills
Additional work details:
- This is a project-based, contract engagement supporting regional Medical Affairs operations
- Estimated full-time weekly commitment, with flexibility depending on project phase
- Collaboration with regional stakeholders across Southeast Asia, with occasional early or late meetings as needed Work is primarily remote, with clearly defined deliverables and timelines
Additional Information
Regional role with periodic travel (10% across SEA)
Occasional early/late calls to support multi-country stakeholders
This is a non-promotional Medical/Scientific Affairs operations role
