Principal regulatory writer

Fully Remote role

Job Summary
We are a specialty pharmaceutical company looking for a Principal Medical Writer to join our team as our first Medical Writer and partner closely with clinical and regulatory teams. The ideal candidate would have worked with a broad range of clinical documents. This role can be home based anywhere.

Job Overview
Who are we:
We are a specialty pharmaceutical company with both an established commercial portfolio and broad range of compounds going through development; including very positive phase II results. This role will require partnering closely with our clinical department and developing the medical writing function. Longer term we are looking to build out a team below this position.

Key Responsibilities

Responsible author of non-clinical and clinical documents Clinical Trial Application (CTA), Investigational Medicinal Product Dossier (IMPD), Product Specification File (PSF), Investigator Brochure (IB), Informed Consent Forms (ICF), Protocol Synopsis and Protocol, Trial Master File (TMF) and Clinical Study Report (CSR) and other supporting documents to support clinical development and/or marketed products as required