Medical Writer

Title: Medical Writer

Industry: Pharmaceutical, Oncology

Term: Anticipated 1 year, potential to renew

Location: FULLY REMOTE (candidates from NY/NY/PA/TX only)

 

Work directly with program and clinical study teams, the Oncology medical writing teams, and the publishing group in the preparation of scientifically valid and high-quality regulatory and clinical documents.

 

  • Responsibilities include preparation of documents in accordance with the ICH guidelines, international regulations, standards and processes, and Writing Style Guide as applicable. Documents include but are not limited to: Protocols and protocol amendments, clinical study reports, investigator’s brochures, and submission summary documents.

 

  • Participate in project team meetings to provide input regarding deliverables, timelines, and processes.

 

  • Responsible for managing the document review and completion process.

 

  • The medical writer should be familiar with ICH guidelines and the current AMA Style Manual.

 

  • The writer will be expected to manage large documents with multiple review cycles and tight deadlines.

 

Qualifications:

  • Bachelor’s degree (life science preferred), RN, Master’s degree in life sciences, PharmD or PhD preferred, or equivalent experience.
  • Excellent medical writing skills, meticulous attention to detail, proficiency using an electronic document management system and standard style guide, and strong analytical ability to interpret clinical data.
  • 5+ years medical writing experience in the pharmaceutical industry.
  • Prior experience in Oncology is a plus.
  • The most important requirement is the ability to independently write regulatory/clinical documents in collaboration with the study/program team members.

Company requires all contractors to be fully vaccinated against COVID-19 and provide valid proof of vaccination as of their start date to their employer/supplier, to the extent permitted under applicable law.