Medical Writer Required

Overview

Researches, writes, and edits clinical and regulatory documents by applying functional expertise and clinical drug development knowledge. Writes clear and concise documents, including study reports, protocols, investigator brochures, summary documents, and other scientific documents. Exhibits excellent written and oral communication and presentation skills. Demonstrates technical expertise and background in the use of medical writing templates and software (eg, PleaseReview, Documentum-based platforms, etc.).

Responsibilities

  • Acts as a lead medical writer on complex programs and numerous individual studies.
  • Represents the medical writing function on project teams, contributing to scientific content, drafting document specifications, and coordinating regulatory submissions and data analysis.
  • Manages all aspects of the medical writing function.
  • Writes and reviews clinical study reports, protocols, and other clinical/regulatory documents.
  • Contributes to clinical protocol development for first-in-human oncology studies.
  • Drive the document preparation process, receive and review primary statistical output, draft and distribute documents for review, and incorporate/resolve comments with all reviewers.
  • Provides scientific and medical writing consultancy to project teams, as requested.

Qualifications

  • Advanced degree in a relevant scientific/clinical/regulatory field preferred
  • At least 3 plus years of experience in medical writing role in the pharmaceutical/CRO industry.
  • Excellent writing skills.
  • Ability to understand and interpret clinical and scientific data; ability to present results in an understandable manner to a variety of audiences.
  • Knowledge of current requirements and guidelines applicable to submission documents
  • Excellent interpersonal and oral communication skills.
  • Strong knowledge of MS Word, Excel, PowerPoint, and Outlook
  • Ability to prioritize multiple projects
  • To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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