Senior Writer / Writer

Location
Waltham, MA
Posted
Mar 12, 2018
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time

Company Overview

Eloxx Pharmaceuticals, Inc.  (http://www.eloxxpharma.com/ ) is a clinical-stage biopharmaceutical company developing novel small molecule medicines to treat many rare and ultra-rare genetic diseases caused by nonsense mutations. Nonsense mutations are a class of genetic defects that result in premature termination of protein synthesis. These nonsense mutations have been identified in over 2,000 rare and ultra-rare diseases.  As a consequence, patients with a genetic disease caused by nonsense mutations have absent or truncated nonfunctional proteins, accounting for some of the most severe phenotypes in these genetic diseases. Eloxx’s lead product candidate, ELX-02, is an investigational, novel translational read-through inducing drug designed to restore synthesis of full-length functional proteins. ELX-02 is an investigational agent undergoing clinical trials and has not been approved by any global regulatory body. Eloxx was founded in 2013 and is headquartered in Waltham, MA. with R&D operations in Rehovot, Israel.

This is an opportunity to join a growing and energetic team, build a high performing company, gain personal development and transform patient lives.

Job Summary

Edits/drafts pre-clinical and/or clinical reports, summarizing data from pre-clinical and/or clinical studies.  Edits, formats, and may draft sections of: clinical study reports, summary documents, protocols, package inserts and other documents that may be submitted to regulatory agencies or used for publication and/or presentation.  Edits, formats and may draft components of scientific manuscripts, abstracts and posters for publication. 

Essential Job Responsibilities

  • Edits/drafts pre-clinical and/or clinical reports, summarizing data from pre-clinical and/or clinical studies.  Edits, formats, and may draft sections of: clinical study reports, summary documents, protocols, package inserts and other documents that may be submitted to regulatory agencies or used for publication and/or presentation.  Edits, formats and may draft components of scientific manuscripts, abstracts and posters for publication. 
  • Develops templates for clinical and regulatory documents including CTD/NDAs, clinical study protocols, clinical study reports, Investigator Brochures, FDA Annual Reports.
  • Edits, formats, and may write reports for clinical, regulatory, publication purposes based on data from Phase 1-4 clinical trials and.
  • Collaborates with clinical and regulatory team members in the preparation and editing of clinical and regulatory documents.
  • Formats and proof reads documents for consistency and compliance with Eloxx Pharma guidelines.

Qualifications/Experience

  • Requires a Bachelors degree in a scientific or language arts discipline.
  • 5-8 years’ experience in the pharmaceutical or biotechnology industry. 
  • Knowledge of GCP, FDA regulations and ICH guidelines is preferred.
  • Ability to travel 10%

Interested candidates can click "Apply now"