Leading Global Company within the Medical Sector is seeking a Country Clinical Affairs Specialist to join their team. You will be responsible for Clinical Affairs internally and externally for a specific country / region. Manage local evidence plans in light of market needs, changing local environment and competitive evidence landscape.

Key areas of focus will include

Actively builds and maintains optimal relationships with local customers and local Key Opinion Leaders as well as with local authorities, medical & scientific communities and the medical device industry
Represents the Company as “the Clinical face” within the country / region and acts at the same time as the “voice” of the local customers and authorities towards relevant stakeholders
Supports and provides input to the local clinical strategy and ensures full alignment with the global clinical strategy for each SBU
Identifies potential local clinical studies in line with local and SBU strategy
Submits potential study proposals to the clinical SBU for approval
Submits ERP’s following the existing SOP’s
Forward approved local studies to the clinical BU, PAN, MCO and / or RCC for execution and facilitates the other departments access
In case needed, takes care of study management for local studies at the request of the BU clinical team
Ensures awareness of local clinical activity and new clinical evidence and provides input to sales & marketing leaders
Advises local marketing organization on outcome of publications and advises on a communication strategy
Ensures strict adherence to regulations and communicates discrepancies to the different stakeholders
Is the point of contact for:
The clinical BU: to approach local market for globally initiated studies
All departments in the Company that need access to the local clinical field
PAN, MCO and RCC in case of local (language, culture, travel)
Facilitating quality audits, safety, legal (contracts), potential studies (MEC) and medical writing
Be the first point of contact for:
Local customers, authorities and KOLs about local Clinical Affairs
Clinical BU: for in-depth knowledge about the local clinical environment and for mandatory consultation on site nomination

Requirements
University Masters or Bachelor’s degree in relevant biomedical field
Deep knowledge on the local culture and language
In depth knowledge of local evidence needs and local law & regulations
5 years relevant experience in the clinical field