Careers

Program/Project Manager

Experienced in planning, directing, and coordinating discovery, pre-clinical, clinical, and regulatory / eSubmission projects in accordance with GxP and/or other related regulations (i.e., FDA, ICH, 21 CFR Part 11, HIPAA, etc.).

Responsibilities

  • Manage and direct one or more project teams to meet complex project objectives
  • Review, develop, and manage project plans, schedules, budgets, and resources
  • Identify and negotiate scope, milestones, and resources needed to meet project objectives
  • Employ industry standard methodologies to guide and execute projects.

Requirements

  • Experience managing projects from inception to successful implementation (7-10 years)
  • Experience with industry regulations (i.e., GxP, FDA, ICH, etc.) (3-5 years)
  • Experience in Computer System Validation. (3-5 years)
  • Experience with 21 CFR Part 11 (2-3 years)
  • Experience with a formal systems development life cycle (5-7 years)
  • Excellent oral and written communication skills
  • Excellent team building and interpersonal skills



To be considered for this position, please follow the
instructions on the main Careers page.