Medical Affairs Manager, Uk & Benelux Cluster Lead F/M

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.
We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.
Achieve, Cooperate, Care and Innovate are the values that we share and practice on a daily basis.
Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.
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Medical Affairs Manager, UK & Benelux cluster leadF/M
Location: UK
Permanent contract to be filled as soon as possible
Guerbet is seeking an accomplished Medical Affairs Manager, based in UK to lead the development of the Medical Affairs strategy and programs within the UK/Benelux cluster.
This role will be responsible to ensure accurate, robust and appropriate medical/scientific exchange with internal and external stakeholders.
OUR OFFER
You will be the signatory medical doctor or pharmacist qualified person for the cluster. A registration as local Qualified Person in Pharmacovigilance (QPPV) for Benelux is desirable.
The Medical Affairs Manager Cluster lead will bring strong leadership qualities, high level of cross-functional collaboration and the ability to influence across all levels of the organisation. Passion for the patient community and commitment to patient advocacy are paramount for this position:
- Implements locally the PV policy according to the Group PV policy, strategy and objectives as defined by the Head of the Corporate PV department.
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Is in charge of the local scientific and regulatory intelligence in PV. Provides his/her expertise and support to analyze the impact of new regulations and to apply them. Is responsible for the local compliance with the applicable quality referentials and their evolution in his country.
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Is the contact person dealing with the authorities for RA
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Checks the legal and regulatory compliance as well as the scientific content of the documentation sent by Corporate RA department. Submits variations, renewals or new marketing authorization applications to his competent authority. Attaches any relevant documentation according to the local requirements.
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Manages product quality complaints.
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Checks the compliance with the good practices (GMP, GDP, GCP).
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Implements locally and communicates about the quality assurance system and its evolution.
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Revises and approves promotional materials according to the law in force.
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Revises and validates the scientific documentation used for the education of the sales force (e-learning ).
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Is responsible for providing medical information whenever a customer is asking a scientific, medical or radiological question related to the products.
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Participates to the Medical Information Network dealing with such questions at the Group level.
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Is the contact person dealing with the authorities and ethical committees
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Identifies clinical sites with potential investigators for future clinical studies. Proposes them to the Corporate Clinical Development department.
YOUR PROFILE
- Scientific degree (MD, PhD or PharmaD) AND ABPI certification are essential
- Confirmed experience and qualifications to locally mange PV and RA activities
- Good knowledge about the administrative tasks related to clinical studies.
- Good competencies in contrast media and medical devices are an asset
- 5 years' experience or more in Biotechnology/Pharmaceutical/Medical Devices field
- Prior experience as a Medical Affairs Manager is a must.
- Proven track record of relationship development in the industry.
- Proven ability and experience to present complex scientific data.
- Prior exposure to complex matrix organizations or experience working as part of a virtual team is a plus.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organizational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
- Fluent in English
- Desirable: Dutch & French both spoken and written.