Regulatory Medical Writer

Title: Regulatory Medical Writer

Industry: Pharmaceuticals

Contract Term: Anticipated 1 year (possible extension or temp to hire)

Location: Bergen County NJ 

Candidates must be commutable for a minimum of 3 days on site weekly. This is a full 40 hour work week.

Must haves:

  • 5+ years’ writing experience in the pharmaceutical industry
  • Oncology experience

The Role:

  • Work directly with clinical study teams, the Oncology medical writing teams, regulatory affairs personnel, and the publishing group in the preparation of scientifically valid regulatory documents.
  • Responsibilities include preparation of regulatory documents in accordance with the ICH guidelines, international regulations, company standards and processes, and Writing Style Guide as applicable.
  • Documents include but are not limited to: Protocols and protocol amendments, clinical study reports, Investigator brochures, and submission documents.
  • Participate in project team meetings to provide input regarding deliverables, timelines, and processes.
  • Responsible for managing the document review process. Route documents for approval.
  • Format and manage long documents with multiple review cycles and tight deadlines.

Qualifications:

  • Bachelor’s degree in life sciences, RN, Master’s degree in life sciences, PharmD or PhD preferred.
  • Excellent regulatory 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.
  • Experience: 5+ years’ writing experience in the pharmaceutical industry.
  • Familiarity with ICH guidelines and the current AMA Style Manual.
  • Accepted file types: doc, pdf, txt, docx.