Senior Regulatory Affairs Associate - Clinical / Nonclinical Writing

Parexel International Corporation

USA - Any Region - Home Based


If you love writing, have a passion/interest in Regulatory Affairs, and are looking for an opportunity to say good-bye to the daily commute, then Parexel's Regulatory Consulting team has an amazing opportunity for you!

Our Regulatory Consulting Team is expanding and we are seeking a Senior Associate Consultant to join our team of Regulatory experts and assist our clients with pre-market submissions! This is a great opportunity to continue to expand your Regulatory Affairs experience as you work with and are mentored by some of the Industry's leading experts. You will gain great exposure as you prepare for client and FDA meetings, write various sections of Applications, interact with Industry Thought Leaders and Subject Matter Experts, etc..

A Senior Associate must have a knowledge of the organization’s basic consulting models and methodologies, as well as basic knowledge of what services PC provides. A Senior Associate must be technically competent and continually developing the skills as defined in the responsibilities section of this document. An Associate, under the general direction of a Project Technical Lead, takes responsibility for ensuring that client work is performed, and delivered on time, meeting the quality expectations of PC and the client. The guidance of more senior staff may be needed to accomplish more complex tasks.QualificationsA Senior Associate Consultant serves as a technical subject matter expert in support to FDA regulatory projects, writing, submissions, etc.

To be successful, you must have the following:


Client-focused approach to work

Results orientation

Teamwork and collaboration skills

Consulting skills

Excellent interpersonal and intercultural communication skills, both written and verbal

Critical thinking and problem-solving skills

Proficiency in local language and extensive working knowledge of the English language

Knowledge and Experience:

2-3 years of experience in an industry-related regulatory affairs environment with a Bachelor's or Master's Degree will be considered or candidates with PhD's who are looking for an opportunity to grow a career in regulatory affairs.

Demonstrated writing experience with some past experience writing clinical and or npn-clinical regulatory documents is highly preferred

This is a home-based role; however, @ 30% domestic / international travel may be required in the future

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.

2020-07-17 01:00:50

Apply to this job