Principal Medical Writer (6-12 Month Remote Contract)

Precision Life Sciences - Boston, MA

Our client is seeking a Principal Medical Writer for a remote, 6-12 month contact. This role independently plans and prepares a variety of clinical documents necessary for all phases of clinical drug and device development by organizing, analyzing, and interpreting scientific and statistical data. Such documents include Module 2 clinical summaries of marketing applications, integrated summaries of safety and efficacy, clinical study reports, study protocols, investigator’s brochures, aggregate safety reports, and manuscripts.

As a Principal Medical Writer You Will...

  • Conduct overall planning and writing of the clinical sections of global marketing applications and other regulatory documents.
  • Develop timelines and resource plans for the clinical sections of submission or implementation of communication strategy.
  • Review statistical analysis plans as required.
  • Perform “peer” review of documents written by other medical writers as required.
  • Mentor junior members of the Medical Writing department.
  • Keep management informed on the progress of documents and other project-related information.
  • Assist management in projecting resources and performing administrative duties as requested.
  • Work independently with the sponsor representative(s) with regard to document planning, review, revision, and finalization.

Documents are to be completed within a time period that supports project needs and deadlines. Furthermore, documents are to be of high quality and scientifically accurate and are to reflect a consensus among team members that is acceptable to all appropriate reviewers. Documents must meet International Conference on Harmonisation (ICH) guidelines and company document standards unless required otherwise by the client and agreed per procedure.

Experience + Requirements

  • Bachelor’s Degree in a science or related field.
  • Minimum of 8 to 10 years of medical writing experience in a CRO, pharmaceutical, or biotechnology setting. Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a case-by-case basis.
  • Working knowledge of ICH and other regulatory guidelines is required. The ability to accurately and clearly present clinical data; strong verbal, written, and interpersonal communication skills; and proficiency in Microsoft Word is required.
  • Broad knowledge of global pharmaceutical regulatory requirements required, and experience in clinical research or other areas of the pharmaceutical industry preferred.
  • Excellent regulatory writing skills (e.g., English usage) and keen attention to detail also are required.

 



Posted On: Wednesday, August 17, 2022



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