Medical Writer- Regulatory

  • Temporary/Contract Positions
  • Northern, NJ

Title: Medical Writer- Regulatory

Contract – Term: Anticipated one year

Location: Northern NJ – PARTIAL REMOTE!

 

Local candidates only please, must be on site a minimum of 3 days/week

  • This role requires 5+ years’ writing experience in the pharmaceutical industry (for a Pharma company)
  • Must have experience with regulatory documentation
  • Looking for strong interpersonal skills, and the ability to work in collaboration with various members of study team
  • Oncology experience required!

 

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 the 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.

Must be familiar with ICH guidelines and the current AMA Style Manual.

Will be expected to 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.
  • Prior Oncology experience required.
  • Accepted file types: doc, pdf, txt, docx.