Biomapas is a functional and full outsourcing solution provider to the global life science industry, with key expertise in Clinical Trials, Regulatory Affairs and Pharmacovigilance. With headquarters in Lithuania and offices in Switzerland, Russia, Georgia, Ukraine, Poland, Kazakhstan and Sweden, Biomapas operations are spread over 5 continents, concentrated in Europe, Russia and former CIS region.
Biomapas is looking for EU HUB Lead to join our global team of experts and support our team activities.
The position is available outside Lithuania as well.
Role responsibilities:
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Team line and operational management (defines assigned team roles and responsibilities, helps to resolve problems etc.) of a dedicated RA HUB team for the dedicated geographic area (cluster of some Europian countries);
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Provision of RA support and expertise for daily Regulatory Affairs activities for the given region and coordination of local partners;
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Escalation of issues related to Local Experts (LEs) to vendor management department. Participation in issues solving and further oversight of LEs activities. Participation in vendor selection process;
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Participation in Performance Management and Development Process (PMDP);
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Participation in meetings to discuss project related activities, workload, issues, change, communications, and updates;
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Leading position in participation and contribution in Audits;
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Ensuring compliance with processes and service quality;
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Can be nominated for PM for smaller project for the given region when PM work is minimal;
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Proposals, Agreements preparation support to PM.
Role requirements:
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University degree in Medicine, Pharmacy, Health Science, Biomedicine field/ studies;
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Regulatory Affairs experience not less than 8 years;
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Fluency in native language and English;
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Decision making skill within limit of responsibilities.
In Biomapas you will find supportive work environment with guarantee for professional and personal development, as well as competitive salary and benefits and many more initiatives that will make your daily office life comfortable.
Please apply to cv@biomapas.com
Be kindly informed that only selected candidates will be contacted.
