Hold accountable to support Investigator Sponsored Studies development and execution.
Provide strategic guidance for the performance of clinical studies related to product development and commercial/marketing activities.
Make appropriate product and procedural recommendations and work closely with doctor/patient related issues for the safety of the devices and clinical study activities.
Ensure high quality scientific communication with local and regional Leading Opinion Leaders or Specialists on a peer-to-peer basis.
Support the development and implementation of local and regional medical and scientific strategies and concepts within the Medical Affairs plan and data generation strategy.
Understand, monitor activities and plan of Government Health Care institutions, industry associations, pressure groups, regulatory bodies, medical and scientific societies and sources of technical innovation.
Be an expert with profound medical-scientific knowledge in the therapeutic area of CRM.
Provide strategic direction for completion of medical opinions, medical platform documents and/or Health Hazard Assessment when applicable.
Review and provide medical input for promotional and commercial activities as requested.
Oversee all local and regional Medical Affairs activities for CRM.
Plan and execute the Medical Affairs programs in CRM for the local and regional geography.
Collaborate with Medical Affairs teams in other geographies to have coherent and effective Medical Affairs projects.
Provide APAC perspective in the discussion and development of global Medical Affairs and Clinical Affairs projects, for example contributing to the periodic review of Clinical Evidence Generation Plans.
Present medical-scientific data at internal and external meetings.
Gain and report valuable insight into treatment patterns and scientific activities in the therapeutic area, through scientific interactions.
Co-develop/review marketing materials.
Manage local and regional investigator-initiated study proposals and grant requests.
Organize and participate in local and regional Advisory Boards and Symposia and coordinate conference attendees.
Prepare and participate in local and regional investigator meetings, recruitment follow-up and study result presentations.
Contribute to the cross-functional team in CRM division; co-develop Therapeutic Area strategy together with business leader.
Requirements
A Science degree: Medical Doctor preferably, Pharmacist or PhD in Biomedical Sciences or equivalent by experience.
Deep knowledge of the therapeutic area, strength in research and interpretation of scientific data.
Insight in CV healthcare dynamics, especially in the field of CRM.
Relevant work experience, scientific acumen and communication skills in order to be accepted by Leading Specialists in peer-to-peer relationship.
Minimum 8 years’ experience in Medical Affairs, and/or Clinical Affairs or Research.
Prior experience in the medical device industry is preferred.
Organizational management experience.
Strong strategic focus.
High customer focus and awareness of the importance of business results.
Strong business acumen.
Able to interact with business leaders as peer.
Able to innovate and to coordinate and drive a complex and changing environment.
Proactive, well organized and team player mindset, with high influential skills.
Creative problem-solving skills.
Able to work within matrix organization and provide leadership.