Project Coordinator/Technical Writer – Simulation Studies
· Simulation Sciences
- Aids in data review including compiling and organizing analytical information from laboratory groups, clients and literature to include in model development.
- Maintains well documented, organized and up-to-date study files including proposals, model inputs, reporting, and correspondence.
- Assists in the development and maintenance of standard report/power points/table formats as required
- Responsible for and drives report production under guidance from modelers and management.
- Learns to deputize for modeling scientists in their absence with ability to provide updates to internal/external customers
- Reviews client comments and makes decisions in conjunction with modeling scientist to ensure that all necessary report/raw data clarifications are completed.
- Develops a deeper understanding mechanistic, physiologically-based pharmacokinetic (PBPK) modeling and simulation approaches to integrate knowledge of pharmacokinetics, pharmacodynamics, efficacy, safety, patient demographics, and pathophysiological factors.
- Prepares for and facilitates study update calls with clients under direction of the modeler and management.
- Proactively communicates with support teams on project status and to ensure key milestones are achieved.
- Reviews progress and study status against initial work plan. Maintains an awareness of the financial status of ongoing studies, including work scope changes.
- Discuss software applications with clients and prospects on telephone or in person.
- Writes, reviews, and/or edits publications (manuscripts, abstracts, poster presentations, etc.)
- Performs other related duties as assigned.
- This position reports to the Director of Operations
BS or Master’s degree (or equivalent) in Pharmaceutical Science, Biology, Biochemistry, Chemistry or related fields.
- Minimum of six (6) years’ experience as Scientist, Project Manager, Technical writer or related.
- Experience should include project management and report writing of laboratory or consulting projects supporting PK/PD, PBPK, or toxicokinetic modeling of compounds across multiple phases of drug development. It should also include supporting internal or external clients in decision based projects that have been submitted to regulatory agencies.
- Excellent oral and written communication skills.
- Demonstrates and communicates a positive attitude while interacting with colleagues and clients at all levels.
- Must be able to multitask and have strong organizational skills.
- Self-motivated with ability to work with minimal supervision.
- Some travel required (<20%).
Lancaster, CA, though remote options will be considered.
Competitive base salary + merit-based bonus.