In line with overall product strategy, the Medical Advisor is responsible for supporting the design, implementation and execution of Medical Affairs plans for assigned Therapy Area, providing scientific information, helping design and organise clinical studies, building educational dialogue with KOLs and regulatory stakeholders.
- Support country medical affairs strategy in line with the global strategy, country insights and market conditions, and secure implementation of planned Medical Affairs activities within the designated therapy area(s).
- Coordinate scientific meetings, symposia, congresses, Continuous Medical Education (CME) and other medical / scientific exchange and engagement activities which could bring additional value to the relevant therapy area; develop strategic engagement plan(s) for country customer-facing medical activities and events, and ensure timely execution of planned medical affairs activities in an efficient and compliant way.
- Ensure medical enquiries are responded to in a high quality, timely manner, and in accordance with applicable standards; establish standard response documents as appropriate, for frequently asked questions. Or give necessary support to the Medical Information Department in the development of Standard Response Letters and thoroughly review these.
- Provide medical/scientific input into the development and execution of clinical trials or clinical research related activities, including initiation and oversight of clinical studies/clinical research within the respective therapeutic area. Support country strategy for Non Interventional Studies/Investigator Initiated Trial activities.
- Coordinate review and approval of medical materials and locally developed promotional materials; ensure medical materials provided from global or region for stakeholder engagement and events are tailored to local needs, and reviewed/approved per local guidelines.
- Ensure medical insights are provided to cross functional groups, including, but not restricted to: Pharmacovigilance, Regulatory affairs, Market Access, QA, Commercial teams, Brand team and others.
- Responsible for risk identification and assessment, mitigation planning as well as implementation and monitoring of appropriate internal controls within the area of responsibilities.
Key Performance Indicators (KPIs):
- Works within Ethics and Compliance policies
- Achievement of annual targets for medical activities
Education & Qualifications:
- Minimum Bachelor / Master degree
- English, Dutch and/or French
- Collaborating across boundaries
- Operations Management and Execution
- Project Management
- Applied Business Insights
- Business Mindset
- Continuous Learning (Dyn.Knowledge Development)
- Joint Value Creation
- Operational Excellence
- Project Excellence
- Stakeholder Engagement
Technical / Functional Skills & Knowledge:
- Clinical Trial Design, Data & Reporting
- Medical Education and Scientific Engagement
- Medical Governance
- Medical Safety
- Medical Science and Disease Area Knowledge
- Non-Interventional Studies (NIS) / Epidemiology Studies
- Investigator Initiated research / studies
Qualified candidates possess a bachelor's or a Masters’ degree in life sciences. A minimum of two years of experience in a clinical trial environment is required. Individuals with at least two years of experience in a health sciences field with formal training in medical terminology and anatomy will be considered. Travel can range from 20-60% on a national level or dependent on the project up to 80% international travel.