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Job Function:

Medical Affairs Group:

Job Sub Function:

Medical Affairs – Marketed Products

Job Category:

People Leader

All Job Posting Locations:

Paranaque, National Capital Region (Manila), Philippines, Petaling Jaya, Selangor, Malaysia, Singapore, Singapore

Job Description: Scientific Affairs Manager, Medical Operations(J&J Med Tech, Southeast Asia)

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

Function: Medical/Scientific Affairs (Med Tech)

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 SEA—Medical Information (MI) requests, copy review (MLR - Medical-Legal-Regulatory), patient safety/vigilance interface, and performance dashboards—so 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 (Med Tech 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:

• Bachelor’s or higher in Life Sciences, Pharmacy, Biomedical/Clinical Engineering, Data Science (advanced degree a plus)

• 5–8+ years in Med Tech/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 ≤ 30–60 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/Med Comms, IRMS (or equivalent).

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

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

• Collaboration & BI: Share Point/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:

Science Policy, Scientific Analysis, Scientific Papers, Scientific Research, Scientific Work

Preferred Skills:

Analytical Reasoning, Clinical Research and Regulations, Clinical Trials Operations, Communication, Developing Others, Healthcare Trends, Inclusive Leadership, Leadership, Medical Affairs, Medical Communications, Medical Compliance, People Performance Management, Product Strategies, Program Management, Scientific Communications, Strategic Thinking