Full time, Princeton, NJ
Reports to Director of Clinical Research
- Writing and reviewing clinical study-related documents (e.g., protocols, clinical study reports, investigator brochures)
- Review and analysis of study data, and interpretation and summarization of the study results
- Scientific expertise in order to contribute to protocol development and data interpretation
Estimated Time Allocation:
- Prepare clinical protocols, Investigator brochures and supplements these documents (draft outlines and write protocols; coordinate review meetings; prepare amendments as needed, finalize and version-control
- Coordinate, review and revise clinical study reports (critically review CSRs for accuracy, adherence to the protocol, and overall content; coordinate inter-departmental reviews; compile information for appendices) 25%
- Search and review literature sources in order to contribute to study designs and data interpretation (focusing on therapeutic areas, biomarkers, methodology, trial designs/results, competitors’ products), and summarize/present findings 10%
- Prepare and review clinical and non-clinical data summaries for regulatory submissions (investigators brochures and supplements, as well as INDs and annual reports) 15%
- Review data listings, TLFs, and prepare top line data presentations as needed 10%
- Review trial-related documents from other departments (case report forms, statistical analysis plans, informed consent forms) 5%
- Participate in SOP committee meetings, and update/create clinical research SOPs as needed 5%
- Additionally, performs other duties as required and assumes other responsibilities as assigned by the supervisor/manager.
- Minimum of 2 years (10 with a BS) of experience writing and reviewing clinical trial-related documents within the pharmaceutical industry
- Strong scientific background and medical writing skills; knowledge of GLPs, GCPs, ICH guidelines and requirements for the successful conduct of clinical trials; strong computer skills
- Must have strong oral and written communication skills and ability to work well in inter-departmental groups
- Graduate degree in a science/life sciences discipline or equivalent/related education or BS with extensive experience
- The work is performed in an office environment most of the time.
- Travel is required on an as-needed basis (e.g., for training, site visits and meetings).
Contact: Laura Walton; firstname.lastname@example.org