Senior Regulatory Affairs Associate - Medical Writer

Parexel International Corporation

Bucharest, București, Romania

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 medical dossier in CTD format (Modules 4 and 5) Preparation of nonclinical/clinical sections of regulatory documentations (Pre-IND, SA, etc) QualificationsIdeal candidate will possess: Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced degree preferred Several years of experience in an industry-related environment 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 Fluent English and Romanian

2021-08-25 00:05:35

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