Medicines and Medical Devices Shortages Officer

MEDICINES AND MEDICAL DEVICES SHORTAGES OFFICER| FULL-TIME 40 HOURS | EUROPEAN MEDICINES AGENCY | AMSTERDAM

We, Akkodis Life Sciences, are looking for a Medicines and Medical Devices Shortages Officer who can strengthen the team at our customer, European Medicines Agency, in Amsterdam.

Your responsibilities are

• Facilitate the coordination of the implementation of the new legal mandate of EMA in the area of medicinal products and/or medical devices shortages;
• Provide scientific secretariat to the Executive Steering Group on Shortages and Safety of Medicinal Products and/or the Executive Steering Group on medical devices;
• Monitor any events which may lead to a major event or a public health emergency, and which may affect the supply of medicinal products and/or medical devices;
• Manage and support the EU network and industry network of single point of contacts (SPOC Network and i-SPOC), and monitor and analyse the data on shortages with view to identifying any potential or actual shortages of medicinal products and/or medical devices;
• Support the establishment and ongoing review of a list of critical medicinal products and/or medical devices, collect demand data for a specific list of medicines and/or medical devices from all National Competent Authorities (NCAs) through the EU network of single point of contacts;
• Coordinate collection of information on mitigation plans including production and supply capacity from industry;
• Review, analyse and aggregate the data submitted from NCA SPOCs to estimate demand in EU/EEA countries, match these data with aggregated supply capacity from industry, to support the Steering Group on the draft of recommendations on any measures to prevent or mitigate potential or actual shortages;
• Manage potential or actual shortages of CAPs;
• Provide scientific support to the activities of relevant group(s) on availability of medicines;
• Provide scientific secretariat to relevant group(s) on availability of medicines.

Communication and professional contacts

• Required to regularly communicate (verbally and in writing) information, which requires careful explanation and interpretation, taking into account what to communicate and how best to convey the information. Writing and creating information that is specialist, sensitive, confidential, legal and/or regulatory in nature.
• Regular professional contacts with others inside and/or outside the Agency on functional matters. Solicits/gives information, provides advice/guidance and should use initiative. A likely requirement is to influence others’ thinking and negotiate with various parties within own job responsibilities. Normally connected to the Agency's core business or a project.

Welkom bij Akkodis

We are Akkodis. We put the talents, skills and ambitions of our Consultants first. Because we continuously offer you challenging projects, you continue to develop and you can realize your ambitions. This is our view on good employment practices. We, Akkodis Life Sciences, offer you internal and external projects in the field of QA, QC, PV, RA, R&D, Supply Chain and related.

We have +/- 60 Consultants working at the EMA, Astellas, Unilever, Corbion, MSD, Organon, Aspen and many more! 

Kandidaat Profiel

• A level of education which corresponds to completed university studies of at least three years attested by a diploma - Scientific (pharmacy, chemistry, biology or an equivalent) or technical (e.g. applied science) discipline;
• Up to 3 years of full-time relevant professional experience;
• In supply chain and manufacturing of medicinal products for human use and/or medical devices obtained through previous work in academia, industry, notified body, EU competent authority;
• In interaction with stakeholders such as patients, healthcare professionals, academia, pharmaceutical and/or medical device industry;
• In working in a multicultural environment;
• Experience in CMC and Regulatory Affairs;
• Experience in the EU regulatory aspects related to the medicinal product and medical device lifecycle, from research and development, manufacturing to authorisation and post-marketing;
• Project management experience in leading, coordination, planning, implementation, evaluation and timely delivery of projects.
• A clear understanding of the role of EMA within the legislative framework for the regulation of medicinal products and medical devices.

Are you interested in this challenge, or do you want to come in touch?

Please contact your Talent Acquisition Specialist of Akkodis Life Science by sending your CV* and motivation letter to lifesciences@akkodisgroup.com