-Implementation ISO 15189 of the Quality Manual of the P4ML Laboratory -Good knowledge EU 2017/745 and Regulation EU 2017/746 -Good Knowledge of ISO 15189 v2007, v2012, v2014 -Good knowledge of ISO 17025 v2005 and cor 2006/- Knowledge of ISO 9001 -Good Knowledge of ISO 13485: 2016 Quality management for medical devices -Good Knowledge of ISO 14971/ ISO 11607 -Respect of the recommendations of the Royal College of Pathologists of Ireland (RCPAth) for pathology laboratories -translation in French of the booklet "The value of non-invasive prenatal testing (NIPT)" of the brochure "the reassurance of knowing" + Eolas Plus Prenatal Test
1 / Ensure the administrative management of projects 2 / Ensuring the update of the administrative platform of managed projects 3 / Ensure the management of the files of classification of the studies, 4 / Ensure the follow-up of the service providers for the printing, translation and supply of specific equipment activities 5/Realize, at the request of the promoter, help tools for the centers Therapeutic areas: Oncology, organ transplantation and self-modulation,Heavy heumatology, Interventional Cardiology, Degenerative Neurology, endocrinology, IDS )
Watch out for future regulatory trends ahead of public communication
Provides within the LFB all the positions on the regulatory impact that can be have the pharmaceutical regulatory news on its activities,
informs internally and mobilizes trades skills on regulatory texts pharmaceutical products under design, consultation or revision,
Promote these positions with health regulatory agencies during meetings
Update the Regulatory Competitive Intelligence Database (AMM, PIP, SDG) . Safety Drug (March 2017 to September 2017) -Management Procedures: ICSR spontaneous and solicited/ -Management of the SDEA file -Safety Data Exchange Agreement (writing management of an SDEA, update of the templates compliance with local regulations)
Companies of business lawyers from major French and English firms, who advise (companies and managers) on a daily basis in the definition of strategies and decision making throughout the life of business.
-Provide theoretical or practical instruction to students. -Pursue and publish basic and applied research. -Provide work methods to students and coach them -Assist and advise students in their work. -Participate in the development of research programs
