Director, EU Medical Affairs - Nordic Countries

Job Description
Summary

The Director, EU Medical Affairs / Nordic Countries, will be the Nordic Medical Affairs representative of Raptor Pharmaceuticals Europe B.V. with a prime focus on providing medical, clinical and scientific expertise as well as managing interactions with internal and external stakeholders, key opinion leaders, etc. The successful candidate is required to have an excellent level of written and spoken English as well as being fluent in at least one of the Nordic languages.

This role is home based. The Director, EU Medical Affairs / Nordic Countries, may be required to work at the Raptor Pharmaceuticals Europe B.V. office in the Netherlands.

Responsibilities

Provide medical, clinical and scientific expertise as well as guidance on the life cycle of pre and post approved products along with managing interactions with interfacing departments at the company headquarters in the US and in the regional and country organization.
Develop the medical strategic pathway in the Nordic region.
Establish the medical structure within the Nordic organization.
Responsibility and scientific support for pre- and post-launch activities for an orphan indication.
Deliver scientific presentations to internal and external stakeholders.
Provide medical input and review of training materials, to ensure accuracy of content.
Support and ensure appropriate translation of scientific results into strategic product/brand and medical plans. Prepare the medical and scientific evidence in collaboration with Market Access to communicate the benefits of marketed products.
Develop and maintain ongoing relationships with external key opinion leaders (KOLs), healthcare professionals, government authorities, funding bodies and other entities.
Responsibility for the local medical success of global development projects.
Develop an integrated health care network.
Be a strong interface for internal stakeholders from the medical, compliance, regulatory and clinical areas.
Ensure product and disease training to internal and external customers.
Identify risks and benefits within identified therapeutic areas.
Budget responsibility for medical activities.
Active KOL engagement including advisory board/expert group/Nordic meetings planning and development.
Act as medical review officer, responsible for correct printed labeling materials according to the SPC for any educational or promotional materials.
Participate in congresses and external meetings.
Monitor performance of phase IV activities (e.g. value creation through publication of clinical study results).
Work closely with global, regional and country medical affairs representatives in US, Europe and emerging markets and participate as an active member of the Global Medical Affairs (GMA) team.
Ensure effective and consistent communication with internal/external stakeholders within EU in support of regulatory operations, clinical operations, Pharmacovigilance/ drug safety and medical information.

Requirements/Skills

MD with at least 3 years’ hands- on experience in Medical Affairs, Medical Science Liaison or Medical Affairs Manager experience preferred.
Experience in biotech or pharmaceutical industry.
Experience with orphan or highly specialized disease areas, and with key opinion leaders. Working in less mainstream therapeutic areas is an asset.
High-level medical, scientific and clinical knowledge.
Thorough knowledge of drug development process, pharmacokinetic principles, pharmacology and therapeutics.
Experience with orphan diseases.
International working experience desired.
Experience interacting with health authorities, knowledge of GCP and IHC requirements, including regulations regarding promotional materials.
Strong knowledge of the market penetration and access requirements, encompassing medical strategies and market trends.
Ability to work within a cross-functional and matrix organization structure.
Strategic thinking in combination with a strong operational approach; hands-on mentality and a pioneering spirit is the key for success.
Driver of communication and negotiations with an empathic, involving, however confident way; your intercultural competence supports professional cooperation.
Ability to set priorities.
Excellent presentation skills supporting the ability to liaise with business partners and to present ideas and strategies to management.
Highly flexible when it comes to travelling (30-40% of the time) and to work in a fast moving environment.
Besides the academic background and the toolbox necessary for fulfilling this role, we are searching for a strong personality who is interested in being part of a small and growing organization and is willing to make a difference! Are you ready for a real challenge?

DS

Company

Raptor Pharmaceuticals Corp.

Job Code

State or Province

California

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