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.).
- 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.
- 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.