Senior Regulatory Affairs Associate - Non/Clinical Regulatory Writing

Parexel International Corporation

USA - Any Region - Home Based


If you love writing, have a passion for Regulatory Affairs, 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, then Parexel's Regulatory Consulting team has an amazing opportunity for you!

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

In this role, you will:

•Serve in the capacity of Regulatory clinical technical writer and as US Agent and as a Regulatory Generalist

•Prepare regulatory submissions to FDA across a diverse portfolio of product types (small molecule, biologics, combinations), development phases, and scientific disciplines (nonclinical, clinical, general regulatory and/or device). Authoring of Clinical Overviews (CTD Module 2.5) and Clinical Summaries (CTD Module 2.7)Preparing CTD modules 4 and 5Authoring clinical sections of regulatory documentations (IMPDs, Scientific Advice Briefing Documents, Investigator Brochures, Pediatric Investigation Plans, Orphan Designation Applications, etc).Non-Clinical Authoring:pIND – MRL, BDIND – IB, Modules 2.4, 2.6.1, 2.6.2, 2.6.3, 2.6.4, 2.6.5, 2.6.6, 2.6.7, 4NDABLACDPSPA•Support multi-functional projects as project manager and collaborate with technical leads and clients to perform the work

•Review documents to provide quality assurance for both pre- and post-approval regulatory document submissions.

•Produce first-time quality work to meet expectations of both project lead and clients.

•Foster a strong network of colleagues through continued interactions during project engagement QualificationsPhD with industry-related or academic focused regulatory affairs experience OR MS/BS in a scientific discipline and 2+ yrs regulatory affairs clinical regulatory writing experience Ability to summarize regulatory guidelines and apply them appropriatelyAbility to understand and interpret clinical/non-clinical data from different sourcesExperience authoring regulatory documents FDA submissions (i.e. meeting materials and IND/NDA/ or BLA documents) or writing in peer reviewed journalsExperience with safety reports (DSUR, PSUR) is a plusProject management and consultant experience necessary P revious US Agent/liaison experience with health authorities is highly valued, but not required E xcellent interpersonal and intercultural communication skills, both written and verbal required

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.

2022-07-02 00:05:21

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