About

Project Coordinator/Technical Writer – Simulation Studies

Simulations Plus in Lancaster, CA

Department:

· Simulation Sciences

Responsibilities:

  • 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

Education:

BS or Master’s degree (or equivalent) in Pharmaceutical Science, Biology, Biochemistry, Chemistry or related fields.

Qualifications:

  • 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%).

Job Location:

Lancaster, CA, though remote options will be considered.

Compensation:

Competitive base salary + merit-based bonus.

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