Sea Medical Information and Compliance Lead

Position Summary:

- Shape, Implement and drive timely, consistent and quality medical information support for customers in SEA markets.
- Development of high-quality medical information inquiry response documents, training, and escalation processes, leveraging global documents and SOPs
- Shape and Lead future strategies for Medical Information in SEA.
- To ensure compliance excellence in all matters related to MAF best standards and processes in compliance and audits.

Principal Responsibilities:

- Medical Information
- Partner with Regional and Local medical information leads to ensure there is a clear process for managing and documenting unsolicited Medical Information Enquiries (MIEs) received by Janssen and the development and provision of Medical Information Responses (MIRs) to enquires.
- Lead MIOTF (Medical Information of the Future) for SEA
- Identify and implement effective and efficient MI training and procedures through new tools, systems, and experiences from internal and external best practices
- Partner with Information Technology during implementation of a regional service cloud case management system that is integrated with our business processes
- Partner with Drug Safety and Pharmacovigilance to ensure accurate and timely reporting of adverse events and product quality complaints
- Assist in ensuring the provision of quality response documents that are scientifically balanced and evidence-based, adhering to key topics and exhibiting proper language with regulatory / safety /privacy/ legal aspects considered.
- Established Brands Medical Information
- Analyzes caller’s questions to formulate an accurate and concise response using approval resources and records MIEs and interactions in the appropriate databases
- Identifies, records and triage adverse events and product complaints according to internal guidelines
- Work closely with internal contacts to resolve complex inquiries. As needed, researches medical literature and drafts responses for such inquiries.
- Compliance Management
- Ensure that quality and compliance are top of mind for all SEA MAF staff and that SEA MAF is always audit-ready
- Develop a strategic plan for improvement of processes and guidelines based on relevant regulations, laws, HA findings and CAPAs
- Review global and regional SOPs and ensure impact assessments are in done in a timely manner
- Develop SEA MAF SOPs and to ensure SEA and local teams are trained on the SOPs
- Responsible for training team on relevant MAF SOPs to prepare for audits; and to support Cross function teams during audits
- Accountable for review MAF related audit reports and ensure MAF training records are continuously updated
- Ensure appropriate documenting, tracking and escalating non-Compliance issues.
- Attend regional compliance lead meetings
- Ensure External and Internal Compliance
- Assist in training local medical information leads, call center vendors (if applicable) and other business partners on the ongoing science of our products, regulatory labels in respective geographies and managing the pharmacovigilance and business quality reporting in a timely manner for the region
- Assist in ensuring that quality and timeliness metrics are met, that relevant insights are captured from MIEs and prepare regular MI reports in coordination with global and local MI teams
- Centralized MI Mailbox/Call Centre Management
- Set up and management of regional centralized MI mailbox or contract call centre vendors working in close alignment with medical, pharmacovigilance, business quality, procurement, and technology teams
- Manage the centralized MI mailbox or regional call centre vendors to ensure contact centre program complies with regional AE and PQC reporting, Standard Operations Procedure (SOP) and Work Instruction (WI).
- Projects Partnership
- Partner internally on relevant Digital Transformation, Innovation, and technology projects.

**Qualifications**:
**Experience and Competency Requirements**:

- Minimum 5 years of work experience
- Minimum 2 years of clinical work experience preferred
- Solid knowledge of various TAs
- Experience in pharmaceutical industry is preferred
- Good understanding of medical affairs compliance
- Bachelor’s degree or equivalent is required
- Advanced Scientific Degree (MD, Ph.D., PharmD) is strongly preferred
- Ability to conduct medical/scientific literature online searches, along with developing Medical Information Request (MIR) case documentation is required.
- Excellent presentation skills
- Strong verbal and written communication skills

**The role involves extensive interactions with**:

- Regional and local teams
- Healthcare Compliance
- Regional and local Medical Information team
- Drug Safety and Pharmacovigilance
- Medical Team leaders and members