Scientific Affairs Manager, SEA Medical Operations

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Scientific Affairs Manager Medical Operations

(J&J MedTech Southeast Asia)

Job Location: Any Southeast Asia Market (SG/MY/TH/PH/ID/VN)

Function: Medical/Scientific Affairs (MedTech)

Reports to: Head of Medical/Scientific Affairs SEA

Career level: Manager (people & program leadership)

Team: Manages internal and external talents and vendors

Employment: Full-time

Role summary

Lead manage standardize and continuously improve core Medical Affairs operations across SEAMedical Information (MI) requests copy review (MLR - Medical-Legal-Regulatory) patient safety/vigilance interface and performance dashboardsso that decisions are compliant timely and insight-driven. Orchestrate cross-functional partners (Regulatory Quality Legal/Compliance Marketing Commercial Excellence Data/IT) and ensure processes meet regional regulatory and company standards.

General Responsibilities:

• Accountable for SEA processes SOPs RACIs SLAs and audit readiness in MI MLR Safety interface and dashboards

• Approver for MLR process outcomes within delegated authority; escalates risk to Medical Director/Legal/RA

• Budget co-owner for operational spend (tools vendors training); responsible for vendor selection contracting and performance

• Talent leader for an external enabling team (analysts/coordinators) and matrix leader across country stakeholders

Key responsibilities

1. Lead Medical Information (MI) Operations

• Set regional MI strategy (channel intake triage Standard Response Document (SRD) library governance multilingual coverage) and own SLAs (acknowledge same day; resolve within 2 business days for standard)

• Run end-to-end MI intake triage response documentation close covering all channels (email phone web forms congress booths field escalations)

• Ensure responses are evidence-based balanced and non-promotional; manage unsolicited off-label queries per SOP (appropriate routing/approval/escalation)

• Maintain a Standard Response Document (SRD) library (references version control country adaptations); coordinate approvals with MLR and archive with full audit trail

• Capture and route adverse events (AE) and product complaints (PC) arising from MI interactions to Safety/Quality ensuring follow-through and reconciliation

• Coordinate complex/priority inquiries with Medical Directors/SMEs; publish monthly MI insights (themes emerging risks content gaps) to stakeholders

• Build team capability (field training on MI intake GDP PDPA)

2. Chair Copy Review / Medical-Legal-Regulatory (MLR) Governance

• Run the regional operating model (intake triage calendars approval routing archiving) and own the MLR KPI stack (cycle time first-time-right rework)

• Approve/enforce evidence and claims-substantiation standards; harmonize local adaptations across markets

• Drive simplification & automation (templates checklists first-time-right toolkits) and quarterly quality reviews

3. Patient Safety / Vigilance (MedTech interface) Leader

• Manage medical intake & triage for AEs/PCs; ensure on-time regulatory reporting in partnership with Quality/RA

• Lead basic signal/trend reviews in coordination with the APAC Patient Safety Officer; compile periodic safety summaries and field briefings

• Provide PMS/PMCF inputs and close the loop to field on safety communications (e.g. Dear HCPs with RA/QA)

4. Performance Measurement & Dashboards Owner

• Define KPI taxonomy (data dictionary owners refresh cadence) across MI MLR Safety education/evidence program

• Build/maintain automated dashboards (Power BI/Tableau) ensuring data quality lineage and access governance

• Convert insights to actions via monthly operating reviews; document decisions and measured impact

5. Process Quality & Compliance Governance

• Ownership of SOPs RACIs Operational Performance Metrics and change control for MI MLR Safety interface dashboards; keep the region audit-ready

• Run CAPA for findings/near-misses; facilitate root-cause analysis and standard work updates

• Harmonize processes across countries while allowing for market-specific regulatory nuance and language needs

6. Stakeholder Training & Change Management

• Serve as single point of contact for markets on MI/MLR/Safety interface/dashboards

• Deliver onboarding and recurrent training; publish playbooks quick guides and FAQs

• Drive adoption of tools and ways of working; collect VOC; run continuous-improvement sprints

Qualifications

• Bachelors or higher in Life Sciences Pharmacy Biomedical/Clinical Engineering Data Science (advanced degree a plus)

• 58 years in MedTech/Pharma Medical Affairs Medical Information Safety/Vigilance Regulatory Quality or Commercial Excellence with regional process ownership

• Hands-on experience with MI operations (SRDs unsolicited off-label handling literature referencing GDP privacy) MLR/copy review and device safety/vigilance interfaces (complaints AE intake regulatory timelines)

• Working knowledge of SEA device regulations/codes (e.g. SG HSA TH FDA MY MDA PH FDA ID authorities; IMDRF concepts; ISO 13485/14971) and regional privacy expectations (e.g. PDPA)

• Data/analytics proficiency: advanced Excel; BI tools (Power BI); familiarity with data governance and basic SQL & Python (nice-to-have)

• Project management (PMP/Prince2 a plus) and change management (Prosci/ADKAR a plus)

• Excellent written/verbal English; one or more SEA languages is an advantage

Core competencies

• Customer & patient focus (evidence-based non-promotional mindset)

• Collaborative operational rigor & compliance (audit readiness documentation discipline)

• Cross-functional leadership (facilitation influence without authority)

• Scientific communication (clear referenced MI responses; fair balance)

• Data literacy (define measures interpret trends drive actions)

• Continuous improvement (Agile/Lean/Kaizen simplification)

• Clear communication (concise updates; stakeholder education)

Success metrics (KPIs)

• Medical Information: on-time response rate (e.g. 95% within 2 business days with same-day acknowledgment) response accuracy 100% (no scientific errors) SRD library currency (95% within review cycle) AE/PC capture 100% compliance MI CSAT/NPS

• MLR: median cycle time; first-time-right X%; backlog Y; on-time rate vs SLA; training coverage Z% (Subject to SOP Parameters)

• Safety/Vigilance interface: 100% on-time regulatory submissions (where applicable); intake-to-triage N hours; CAPA closure 3060 days; zero critical audit findings

• Dashboards: data accuracy 99%; uptime 99%; time-to-insight reduction vs baseline

• Governance: SOP/RACI currency; change controls on time; stakeholder satisfaction

Tech Tools & Systems (experience preferred)

• MI & ticketing: Salesforce Service Cloud/Zendesk Veeva Medical Inquiries/MedComms IRMS (or equivalent).

• MLR & content: Veeva Vault/PromoMats (or equivalent).

• Quality/Safety: Complaint handling & vigilance systems (e.g. TrackWise or equivalent).

• Collaboration & BI: SharePoint/Confluence Power BI Advanced Excel.

Additional Working Considerations

• 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

Required Skills:

Preferred Skills: