Medical Advisor

2 weeks ago


Singapore CSL Behring Full time

**Responsibilities**
- Work closely with Therapeutic Area (TA) team by leading in the medical function to accomplish their objectives in a compliant manner and following company values and strategies
- Drive the development of the local medical strategy via therapeutic area clinical knowledge and insight from HCP interactions, with potential to expand regionally in the future
- Development and compliant implementation of the annual country TA medical plan, ensuring alignment with the cross functional TA strategic imperatives as well as Global TA medical plans
- Closely collaborate with colleagues in the development and implementation of the local TA strategy
- Establish effective clinical engagement with external medical experts, medical / scientific associations and other external stakeholders (e.g. patient advocacy groups, payer organizations)
- Development and implementation of TA data generation plan, incl. local data gap analysis for TA
- Oversees management of research grants (incl. investigator-initiated studies) for TA
- Management of country TA Medical budget
- Compliance of Medical deliverables for TA with local laws, regulations & codes, and company processes
- Signatory for country promotional and medical materials
- (Deputy) Local QPPV/ Local Drug Safety Responsible
- TA Medical team is adequately trained and TA specific trainings are in place for cross-functional partners
- Provide up-to-date, high quality and relevant medical, technical and pharmaceutical information on CSL Vifor designated products to external and internal customers
- Involvement in the company’s preparation and management of audits and inspections.
- Provide expertise that support the organisation (e.g. material review and approval, formulary submissions, trainings, and ad-hoc scientific support).
- Act as the point of contact to the local and global team for medical IT systems (including IRMS, PromoMats, Research Solution).

**Key Measures of Success**
- Demonstrated an aligned collaboration within medical leadership team and cross-functional stakeholders to meet corporate goals
- Respected and consulted by global and medical teams from other countries for local medical expertise
- Medical TA plan implemented to meet medical goals aligned with cross functional plans
- Delivered effective external engagement and medical education initiatives for TA
- Execution of local data generation activities and reliable support for global CSL Vifor sponsored and Investigator-Initiated Studies (IIS) for TA
- Demonstrated effectiveness of the medical team measured by appropriate metrics that are defined by Global Field Medical Excellence in alignment with Regional Medical Head
- Compliance with local laws, regulations & codes, and CSL Vifor processes Quality, consistency and effective management of medical information enquiries, incl. documentation
- Local Key Information Documents (KIDS) based on global KIDS, if applicable, in place and up to date
- Successful contribution to internal/external audits or inspections and timely resolution of CAPAs

**Tasks**
- Develop and maintain up to date scientific and medical knowledge and expertise (TAs and products)
- Set clear objectives and communicate clearly to the cross-functional team, e.g. clear medical plan including key deliverables for all
- Bring health care / clinical practice expertise, therapeutic area knowledge, medical insights to cross-functional TA team to guide strategic and operational planning
- Ensure close and regular collaboration with TA brand leads and market access to shape the brand strategy and support the local / regional access plans/submissions
- Develop and implement all aspects of annual TA medical plan aligned with TA strategy
- Share local Medical insights, and align local Medical planning and execution with HQ Medical teams
- Plan and track local TA Medical budget
- Deploy TA Medical budget according to strategy
- Manage resources to achieve optimal effect
- Identify, develop and maintain effective engagement with external medical experts and professional organisations
- Be deeply involved in access strategy development and implementation to assure access
- Develop a local evidence generation plan for TA and ensure compliant implementation of data generation activities. Provide medical leadership to Investigator Initiated Studies (IIS)
- Ensure and contribute to compliant implementation of medical communication plan, e.g. disease awareness, medical education, and country congress activities
- Ensure and contribute to compliant implementation of local publication plans, including local congresses and manuscripts
- Enter HCP engagements through CRM
- Analyze and utilize activities of and insight from field through CRM
- Deliver medical training to field based medical team
- Timely response to medical enquiries escalated by local medical information staff
- Development and approval of Local Key Information Documents (LKID) used by medical information to respond t


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