Job Description

Overall Focus:-

* Authoring of Clinical Overviews (CTD Module 2.5) and Clinical Summaries (CTD Moldule 2.7);
* Preparing CTD modules 4 and 5;
* Authoring clinical sections of regulatory documentations (IMPD's), Scientific Advice Briefing Documents, Investigator Brochures, Pediatric Investigation Plans, Orphan Designation Applications, etc).Qualifications

Education:-
Minimum of a Bachelor's Degree in a Scientific or Technical Discipline, Advanced degree preferred;

Essential Skills and Experience:-
Ability to summarize regulatory guidelines and apply them appropriately;
Ability to understand and interpret clinical data from different sources;
Experience authorising regulatory documents or writing in peer reviewed journals;
Several years of experience in an industry-related environment preferred;
Experience with safety reports (DSUR, PSUR) is a plus;
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.