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.
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.
- 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.
- 3 years ago - save job
Pharmacyclics, LLC is a clinical-stage biopharmaceutical company focused on discovering and developing innovative small-molecule drugs for...