Medical Compliance Senior Specialist
5 days ago
**Summary**
Be a champion of openness, transparency and build 100% compliance culture in Asia Pacific Medical Affairs. Ensure that AP MAF’s activities are conducted in a manner compliant to internal processes and external regulations where applicable. To manage the procedural documents for regional MAF and drive change management and support to the local MAF teams to understand and adhere to new policies. Act as the regional business owner of iMEDICAL systems and partner with MAF IT to roll out system enhancements to local MAF teams.
**Responsibilities**
SOP/Policy
- Responsible for the management/deployment of Cross-Pharma procedural documents and MAF regulated training curriculum in AP. Provide AP specific input to global Cross-Pharma Procedural Document Council
- Create or update Regional MAF SOPs in partnership with HCC, Legal and Privacy, and maintain Cross-Pharma Procedural Document Tracker for AP MAF Region.
- Drive change management and support to the local MAF medical compliance leads to understand and adhere to new policies.
- Ensure timely submission of Pharmacovigilance System Master File every month.
- Facilitate Regional MAF Department with post-event documentation review to ensure they are audit ready.
Systems
- Work with Regional and Global IT and local Business Owners to ensure that the iMedical systems architecture and functionalities support the needs of Local OpCos and maximizes efficiencies.
- Roll out enhancements to iMedical systems to the OpCos (change management and training)
- Represent AP as a Regional Business Owner for iMedical Technology Systems at Global Change Advisory Board Meetings.
Compliance training and onboarding
- Lead Compliance Wise workshops to ensure open dialogue on compliance related matters and build 100% compliance focus culture.
- Coordinate the training curriculum and training assignments for the AP MAF organization (i.e. Systems, MSL Scientific Modules, SOPs/Policies) and monitor adherence.
- Facilitate people managers with new-hire onboarding by ensuring onboarding plans are effective and continuous trainings are implemented.
Budget Management
- Work with Finance to track department budget (i.e. projects and travel & entertainment) across Medical Affairs (including MAO) at a regional level and submit quarterly department budget updates to regional Finance.
Others
- Track performance metrics, develop quarterly Medical Affairs Scorecard
- Support organization of AP MAF department meetings (eg: Townhalls, annual Summit)
**Qualifications**
- Diploma or Bachelor degree in the field of life sciences or business
- Good understanding of healthcare compliance principles
- Fluency in English
- Excellent communication skills, both written and verbal, and strong interpersonal skills
- Excellent organizational skills and time-management skills
- Strong interpersonal, communication and influencing skills at all levels including senior leaders
- Change management and project management expertise
- Experience in Procedural Document lifecycle management
- Occasional travel domestic/international
The role involves extensive interactions with:
- MAF team both regionally and Local Operating Company
- All Medical Team leaders and members
- Procurement, finance and Medical Affairs IT
- Global and Local Business Quality and Compliance Leads
- External vendors
**Primary Location**
Singapore-Singapore-Singapore
- **Organization**
Johnson & Johnson Pte. Ltd. (8435)
**Job Function**
R&D
**Requisition ID**
2206069491W
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