Project Management Consultant, Regulatory

• Integrate self into client environment in order to effectively lead project teams while building positive professional relationships with clients and associates.
• Define project objectives, requirements, and assumptions necessary to structure a project or activity. 
• Plan, schedule, and control project activities to fulfill objectives and satisfy project requirements for life sciences clients.
• Develop and drive integrated project plans, aligning project tactics with project strategy.
• Establish, maintain, and lead high performance project teams, serving as the project advocate within the client organization.
• Lead, coordinate, facilitate, and motivate all associated project resources to gain alignment on project goals and deliverables.
• Lead risk management within project teams, ensuring risks have appropriate mitigation and contingency plans.

• Manage projects within established scope, schedule, and budget while meeting and exceeding IPM project management standards.
• Develop and document high-level strategies for accomplishing specific project objectives.
• Facilitate and lead effective project meetings, manage change and conflict, and develop resource planning estimates to manage project workload and productivity.
• Support project management team members to ensure success of projects while maintaining customer service focus.

Required Experience and Training:

• Bachelor's degree in a science or engineering discipline. Advanced degrees are a plus.
• Industry experience related to IPM's business offerings.  8+ years of experience in the pharmaceutical, biotechnology, and/or medical device industries.
• Project management experience related to IPM's business offerings. 5+ years of experience related to one or more of the following: product development and launch, business process optimization, technology transfer, regulatory submission and/or regulatory compliance, quality assurance, and/or alliance management projects.
• Knowledge and application of a disciplined project management process (Six Sigma and Project Management Professional certifications are a plus).
• Familiarity and success with drug and/or medical device development process from discovery through FDA clearance.
• Working knowledge of regulatory requirements and processes, and the ability to develop viable solutions to regulatory challenges and/or issues.
• Demonstrate independent judgment in determining appropriate regulatory action and requirements for product development, regulatory documents, and compliance to agency requests.
• Demonstrate the ability to convert regulatory strategy to executable tactical plans.

Required Skills and Knowledge:

• Exceptional interpersonal and leadership skills to effectively communicate and build relationships with a broad spectrum of audiences at all organizational levels.
• Sound technical aptitude and proven ability to grasp general knowledge of multiple disciplines and technologies with superior computer usage skills.
• Strong competencies in planning, project management, and organization with the ability to lead multiple activities and resources while maintaining a focus on quality.
• Solid analytical and strategic capabilities and business acumen along with demonstrated work ethic, integrity, and professional conduct and appearance.
• Ability to produce and present clear, concise, and professionally written communications and presentations.

Working Conditions:

• Interstate, intrastate, and international travel up to 50%.
• Field exposure to various manufacturing, industrial, commercial, or institutional environments.

Benefits: 

• 100% employer-paid health, dental, and life insurance coverage for employees and their families
• Annual performance bonus potential
• Match of employee 401(k) contributions
• Business development incentives
• Paid training and certification
• Assistance with relocation