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Medical Writer

Job Title:

Medical Writer

Location:

Woodcliff Lake, NJ

Industry:

Information Technology

Duration:

12 mth minimum

Job Description:

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.
  • Preparation of regulatory documents on behalf of Client in accordance with the ICH guidelines, international regulations, Client standards and processes, and the Client 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.
  • Manage 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. 

Job Requirements:

Candidates need to have VERY STRONG REGULATORY MEDICAL WRITING EXPERIENCE

Qualifications:

  • Bachelor's degree in life sciences, RN, Master's degree in life sciences, PharmD or PhD preferred.
  • Would prefer full time onsite 5 days a week however Client will accept someone to work remotely but must work 3 days minimum onsite.
  • 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.
  • Prior experience in Oncology is a plus. 

The Client is looking for someone with experience working as a MW for a major Pharma. Prior experience in oncology is a plus. The most important requirement is the ability to independently write regulatory documents in collaboration with the various members of study team.

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