Clinical Regulatory Writing Consultant

September 25

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Parexel

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Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions

10,000+

💰 Venture Round on 1990-01

Description

• Responsible for Regulatory technical writing (clinically focused) to support development of clinical documents in accordance with ICH/E6/GCP guidelines to support US submissions, clinical trial applications, and clinical consultation responses for multiple clients.

Requirements

• RA professional with 4+ yrs experience in clinical development that includes writing of clinical technical documents and a strong understanding of ICH/E6/GCP guidelines. • Primarily seeking an experienced Clinical author to support FDA submissions: New INDs Pediatric Plans, Fast Track Applications, Breakthrough Therapy Applications, Orphan Drug Applications, responses to FDA requests, Meeting Request and Packages NDA/BLA submissions. • Ability to interpret data and advice from regulatory authorities objectively, often in the face of strongly held competing views. • Extensive experience of all phases of the drug development process in regulatory affairs, including projects with little or no precedence. • Extensive knowledge of being able to develop product/therapeutic knowledge in a new area. • Previous experience independently authoring clinical modules for FDA submissions is required. • EU submissions experience is a plus. • Previous Biologics experience is required. • Previous device experience is a plus. • Previous experience with oncology or rare disease products is a plus.