Regulatory Medical Writer (Woodcliff Lake, NJ)

Primary Responsibilities:

-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, standards and processes

-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.

 

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.

-5+ years’ writing experience in the pharmaceutical industry.

 

Type: Long-term Contract