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Medical Writer

Job Description

Responsibilities:

  • Clinical / medical writing experience pref. in oncology
  • Experience at bringing together submission content (Mod 2. 5, 2. 7 etc)
  • Experience at working with internal clinical SMEs, pulling together their content into briefing documents / submission content
  • Prior knowledge of Pfizer systems is desirable but not mandatory East coast based preferably
  • Write, edit, and format various regulatory documents, publications, and presentation materials for NDA submission
  • Coordinate document review cycles, incorporate comments, and collect signatures for finalization
  • Develop and maintain timelines for document/publication review and finalization
  • Assist in the development of in-house medical writing materials for NDA submission (such as SOPs and style guide)
  • Provide quality control (QC) review of various regulatory documents
  • Collaborate with others and effectively represent Medical Writing/ Clinical Regulatory on inter-departmental project teams

Qualifications

  • A minimum of a BS degree and 3+ years experience in a pharmaceutical, biotech or CRO environment
  • Demonstrated solid knowledge and Experience in Medical Writing and/ or Clinical Regulatory (IND, NDA, briefing books, DSUR, Literature Writing etc.)
  • Recent experience with an NDA submission desired
  • Experience writing and managing clinical regulatory documents
  • Knowledge of science and clinical research concepts
  • The ability to understand and summarize clinical data
  • Writing ability for different types of clinical and regulatory documents
  • Knowledge of FDA and ICH guidelines
  • Demonstrated solid project management skills
  • Proven experience in working in a high volume environment handling multiple tasks
  • Excellent time and priority management, able to work efficiently under pressure
  • Works accurately and to detail
  • Strong organizational skills
  • Strong computer skills, including Word, PowerPoint, and Excel
  • Excellent grammatical and communication skills, both written and oral
  • Expertise with electronic publishing desired
  • Proven ability to interact seamlessly and collaboratively with client in a consulting relationship

Additional Information

All your information will be kept confidential according to EEO guidelines.

I'm interested

Medical Writer

Katalysthealthcareslifesciences
Remote, OR 97458
Full Time

Published on 04/21/2021

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