Regulatory Affairs Consultant - Medical Writer

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). 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.