Regulatory Affairs Consultant - Medical Writer

3 days left

21 Apr 2021
21 May 2021
Clinical Research
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Job Description

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.Why Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

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