Regulatory Medical WriterWednesday, January 30th, 2019
Title: Regulatory Medical Writer
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.
- 5+ years’ writing experience in the pharmaceutical industry
- Oncology experience
- 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.
- 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.