Senior Regulatory Affairs Consultant - Clinical Writing (Vaccines)

Parexel International Corporation

USA - Any Region - Home Based


If you love writing, have a passion for clinical regulatory strategy, have past experience with vaccines or a desire to learn more about these vital products, and are looking for an opportunity that will allow you to continue to have the flexibility of working from home while gaining tremendous professional experience and working with some of the Industry’s BEST, then Parexel's Regulatory Consulting team has an amazing opportunity for you!

As a Regulatory Affairs Consultant, you will:

Be responsible for Regulatory technical writing (clinically focused) to support development of clinical documents in accordance with ICH/E6/GCP guidelines to support US/EMA submissions, clinical trial applications, and clinical consultation responses. QualificationsQualifications:

1) RA professional with 5-10 yrs experience in clinical development that includes writing of clinical technical documents and a strong understanding of ICH/E6/GCP guidelines.

2) Bachelor’s degree or PhD in science/biological or healthcare.

3) Ability to interpret data and advice from regulatory authorities objectively, often in the face of strongly held competing views.

4) Extensive experience of all phases of the drug development process in regulatory affairs, including projects with little or no precedence.

5) Extensive knowledge of being able to develop product/therapeutic knowledge in a new area.

This role may require <30% domestic and/or international travel in the future

Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination. EEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

2022-05-14 00:05:21

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