Medical Writers

Medical Writers – Oncology

Multiple positions- Direct hire and Contract to hire

Location: Bergen County NJ

 

Qualified candidates will have:

 

  • 5+ years’ writing experience in the pharmaceutical industry.
  • Ability to independently write regulatory documents in collaboration with the various members of study team.
  • Experience with Oncology in a REGULATORY
  • Bachelor’s degree in life sciences, RN, Master’s degree in life sciences, PharmD or PhD preferred.
  • On site capability (Minimum 3 days per week). These are all full time roles with some remote flexibility.

The role:

  • Responsibilities include preparation of regulatory documents in accordance with the ICH guidelines, international regulations, company standards and processes, and the Company 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.
  • The medical writer should be familiar with ICH guidelines and the current AMA Style Manual. The writer will be expected to format and manage long documents with multiple review cycles and tight deadlines.

For the Associate Director role:

Qualified candidates will have:

  • Bachelor’s degree in life sciences ,RN, Master’s degree in life sciences, PharmD or PhD preferred.
  • 8+ years experience writing regulatory documents in the pharma industry.

The role:

  • Lead Medical Writer for one or more oncology programs, responsible for supporting the critical regulatory medical writing needs, and offering direction to other staff/contractors regarding these projects.
  • As the lead writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds’ life cycle management.
  • Due to the complexity of the programs, the incumbent must rapidly acquire complete and advanced knowledge of the compound to ensure alignment and consistency across studies.
  • The qualified candidate will have proven ability to write and effectively manage the document preparation when necessary.
  • Accepted file types: doc, pdf, txt, docx.