Medical Education and Compliance Specialist
J&J Family of Companies
Medical Education and Compliance Specialist
(J&J Innovative Medicine)
POSITION SUMMARY
+ Responsible for end-to -end execution and coordination of digital and face-to -face Medical Education activities
+ Accountability for tracking progress of projects, their execution and financial management of the Medical Education events and projects
+ To ensure compliance excellence in all matters related to MAF best standards and processes in compliance and audit
+ Ongoing project liaison with Medical Science Liaisons and as applicable, APAC/ SEAI and other local operating companies and external stakeholders
PRINCIPAL RESPONSIBILITIES
Medical Education (40%)
+ Work in collaboration with the MSLs to develop Medical Education plan as part of the strategic business planning process, ensuring strong rationale and appropriate budget estimations.
+ To drive the planning, execution, and follow up of Medical Education activities, engaging all internal Operating Company stakeholders, agency partners, and faculty members as appropriate.
+ Oversee agency partners in coordination of Medical Education activities including accountability for tracking progress of projects, their execution, and financial management.
+ Build and maintain strong relationships with the external scientific community (experts, HCPs, scientific societies etc), agency partners, and key internal Regional and Operating Company stakeholders across SEA/Asia Pacific.
+ Coordinate and follow up of the educational grant and sponsorships management process.
+ Support MAF in CPD/ CME submission to relevant external institutions and agencies
+ Support MAF in post-event tracking, filing as appropriate according to document retention and archiving policies
Medical Compliance Management (30%)
+ Review global and regional SOPs and ensure impact assessments are in done in a timely manner
+ Develop local MAF SOPs and to ensure local SOPs are kept updated. To ensure team is trained on local SOPs
+ Responsible for training team on relevant MAF SOPs to prepare for audits; and key support for relevant audits/ inspections
+ Accountable for review MAF related audit reports and ensure MAF training records are continuously updated
+ Ensure appropriate documenting, tracking and escalating non-Compliance issues
Budget Management (20%)
+ Prepare and administer records of all internal orders, purchase orders, requests for payments, invoices, and meeting cards liquidation
+ Responsible for initiation, following up and completion of payment process for all MAF related activities
+ Responsible for budget planning, tracking and reporting of medical education programs, grants and consultancy agreements activities – in accordance with finance update cycles, escalating budget discrepancies as appropriate
Other Medical Operations and Efficiencies (10%)
+ Ensure that all activities are carried out in compliance with regulatory guidelines, HCBI and company policy
+ EPIC Hiperos TPI DD submissions/ renewals – DD evaluation form and Business relationship creation
+ iMedical review of medical education materials, archive MAF materials as appropriate
+ Collate and provide department performance metrics, reporting and communications to internal stakeholders
+ Organize and maintain all department belonging files and archival of MAF related documents/ materials according to document retention and archiving policies.
+ Research related activities, pre-approval access activities and publications approval processe
+ Identify process efficiencies, coordinate the development of process improvements and develop standard operating procedures as needed
**Qualifications**
Education :
+ Medical or science background (pharmacy, life science/ biotechnology)
+ 2 years event planning and management or related area, and preferably in pharmaceutical or healthcare industry experience
+ Project management desirable
+ Fluent both Thai and English
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