Opening with our client for an IT Project Manager with a focus on regulatory affairs and compliance.
In this role, you will oversee the software quality and SDLC processes for projects related to pharmaceutical regulatory compliance industry requirements.
Developing project scopes and objectives, involving all relevant stakeholders and ensuring technical feasibility
Perform risk management to minimize project risks
Ensure compliance with IT Quality and SDLC processes including change management and quality/testing process.
Enforce Systems Development Life Cycle standards and required regulations to projects.
Provides regulatory input to product life cycle planning, and develops regulatory road maps and strategies to drive the life cycle.
Meet budgetary objectives and make adjustments to project constraints based on financial analysis
Delegate project tasks based on junior staff members’ individual strengths, skill sets and experience levels
Ensure that all projects are delivered on-time, within scope and within budget
Mentors, coaches, and trains others in project management best practices.
Create and maintain comprehensive project documentation
Bachelor's Degree in engineering or science field.
Master’s Degree preferred
PMP certification preferred. 6+ years of project management experience
Solid knowledge of SDLC (Software Development Life Cycle)
Regulatory Affairs experience within the drug and pharmaceutical industry required
Working knowledge of US and EU regulatory requirements for pharmaceutical products
Self-starter with solid leadership skills Ability to work well in a team setting and independently.
Must have strong writing, project management and communication skills.
IT Project Manager - Regulatory Affairs - 19971
Internal Number: 19971
About Oxford Solutions, Inc.
Since 1998, Oxford Solutions has solidified our reputation as a reliable, cost-effective staffing solutions provider…whether it’s a mission-critical project of any magnitude, or simply to fill a necessary temporary opening to keep operations running smoothly.