Manager, Medical Writing
Pharmacyclics, Inc. - Sunnyvale, CA

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Summary:

The Manager, Medical Writing, is accountable for all medical writing activities for an individual document within a global development project, and supervises all medical writing resources assigned to that document. S/he also supports other medical writing projects as necessary.

Responsibilities:

Researching, writing, and managing the production of clinical documents and materials, including but not limited to:
  • Investigator brochures, clinical study reports, abstracts, posters, publications, clinical summaries, clinical overviews, protocols, protocol amendments, annual safety updates, and presentations.
  • Reviewing analyses and data presentations to be used in study reports or other documents.
  • Providing input to timelines for completion of clinical documents, and ensuring delivery of documents to meet the timelines.
  • Ensuring that all clinical documents are produced according to appropriate SOPs and business practices.
  • Supervising contract medical writers
  • Developing, implementing and using templates and guidelines for clinical documentation. Potentially providing template training to teams.
  • Reviewing pertinent literature, evaluating its applicability, and incorporating the information into clinical documents.
  • Supporting clinical teams in protocol and CRF development.

Requirements:
  • Manager must Bachelor's degree in a science or communication discipline with a minimum of 5 years medical writing experience in the clinical or laboratory setting OR Advanced Degree with 3 years medical writing experience in a clinical or laboratory setting
  • Good understanding of experimental methods, research design, and statistical analysis.
  • Ability to analyze medical data and interpret its significance within a pharmaceutical setting.
  • Ability to interpret, analyze, and present statistical data obtained in a clinical trial.
  • Advanced scientific, technical reading, writing and editing skills.
  • Excellent oral communication skills.
  • Proficient computer and word processing skills.

Pharmacyclics, Inc. - 2 years ago - save job - copy to clipboard