Director of Medical Writing – Remote Across USA


Job title: Director of Medical Writing – Remote Across USA

Company: Barrington James

Job description: Company:

My client is a large multinational pharmaceutical and chemical manufacturing company engaged on enhancing the health and well-being of patients worldwide. It is focused on research, development, manufacturing and marketing of unique and rare derived therapies, hospital pharmacy products and diagnostic technology for clinical use. They are a large company who’s visions go far beyond anything they’ve ever achieved.

They work in a very rare therapeutic area and operate across Europe, USA, Asia and beyond.

They are offering a competitive package with an opportunity to join a close knit team in an employee first, business second culture.

Job Summary:

Managing the medical writing group that supports globally the Clinical Operations staff both in Spain and the USA. Leading on drug filings and submissions, Assisting with the hiring of medical writers, mentoring and training, whilst providing strategy support and helping grow their medical writing operations and beyond.

Oversees quality control across all documents produced by medical writing and for other documents produced by the clinical operations teams. Manages worldwide registration and results disclosure of clinical studies as required by Food and Drug Agency (FDA) and the European Union Drug Regulating Authorities Trials Database (EudraCT). Writes and functions as a Senior Medical Writer to produce documents such as protocols, clinical study reports, submission dossiers, investigator brochures.

Requirements:

  • Advanced degree: Master’s, PhD, or PharmD preferred. Requires 10 years experience at Bachelors degree. Equivalent of 8 years experience for a Master’s or PharmD degree. Equivalent of 6 years experience for a PhD. Project or technical leadership experience required. Supervisory or management experience preferred. . (If Bachelors degree, equivalency is 10 years direct experience in medical writing and supervisory experience required) Extensive writing of clinical regulatory documents extensively and has experience of training, mentoring and leading teams of junior writers.

If you would like to know more, please do not hesitate to apply!

Expected salary:

Location: USA

Job date: Sat, 06 Aug 2022 22:45:16 GMT

Leave a Comment