Regulatory Medical Writer Consultant

Design Space InPharmatics, a leading international pharmaceutical consulting organization, is seeking an experienced Regulatory Medical Writer to support NDA submission programs for our growing portfolio of drug development clients. We are looking for a consultant with demonstrated expertise authoring and compiling FDA New Drug Application (NDA) submissions, specifically NDA Module 2 and Module 5 content in CTD/eCTD format.

The ideal candidate will bring strong experience in clinical regulatory writing, integrated summaries, clinical study report development, and NDA submission strategy across small molecule and/or biologic drug products. This is a high-impact consulting engagement offering flexibility, and meaningful work at the forefront of regulatory drug development.

Role and Responsibilities

In this high-impact consulting role, the Regulatory Medical Writer will provide expert-level authoring and regulatory documentation support across a range of...