Regulatory Affairs Consultant - Medical Writer in Bucuresti

We are currently looking for a Regulatory Affairs Consultant - Medical Writer in Romania who will have the following responsibilities:- Medical Writing of Clinical and Non-Clinical Overviews (in CTD format: Modules 2.4 and 2.5) and summaries (2.6 and 2.7), concerning efficacy and safety for the medicine products submitted for marketing authorization;- Preparation of clinical and nonclinical medicaldossier in CTD format (Modules 4 and 5;- Preparation of nonclinical/clinical sections of regulatory documentations (Pre-IND, SA, etc). Qualifications• Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced degree preferred;• Several years of experience in an industry-related environment preferred;• Experience authoring modules 2.4 - 2.7 or writing in peer reviewed journals;• Experience with writing clinical summaries (IND, NDA, BLA, MAA), safety reports (DSUR, PSUR) is a plus;• Ability to summarize regulatory guidelines and apply them appropriately;• Ability to understand and interpret clinical data from different sources;• Critical thinking and problem-solving skills;• Time management;• Proficiency in local language and extensive working knowledge of the English language.2021-04-22 00:05:37


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