Project Manager, Risk Management Programs (REMS)

Work Schedule

Environmental Conditions

Job Description

Experience managing REMS programs is STRONGLY PREFERRED for this opening.

Brief description:
Leads cross-functional strategic Risk Evaluation and Mitigation Strategy (REMS) and risk management projects while also leading internal projects and process improvement initiatives. Solves complex problems; takes a new perspective using existing solutions. Works independently and receives minimal guidance.

What Youll Do:

• Serve as the primary contact between the customer and the organization at the project level

• Be accountable for the overall delivery of the cross-functional project (time cost quality)

• Ensure escalation pathways are adhered to internally and externally

• Establish communicate and manage customer expectations to achieve optimal delivery during the project

• Provide direct support (internal and external) including but not limited to conference calls meetings customer problem resolution audits and inspections

• Ensure financial stewardship at a project level by demonstrating an intimate understanding of the contract resource alignment to budget management of out-of-scope activity drive the contract modification process/negotiations and team execution to timelines

• Drive risk identification and issue resolution at project level

• Ensure project team compliance with organization policies SOPs ICH- GCP regulatory and project- specific requirements

• Partner with project team to ensure readiness for audit/inspection by a customer or other entity

• Prioritize projects and day-to-day workflow for self and other team members

Education & Experience Requirements:

• Bachelors degree or equivalent

• Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 5-8 years)

Knowledge Skills Abilities:

• Technical and systems competency to include effective use of systems and applications such as Microsoft Outlook Word Excel and PowerPoint as well as organization applications and platforms

• Ability to delegate and effectively prioritize workload in a frequently changing environment

• Excellent communication (i.e. presentation and written listening verbal) and customer service skills including the ability to lead motivate and coordinate cross-functional project teams

• Strong analytical planning risk and issue identification and resolution skills required

• Effective communication with internal and external individuals in various functional areas and at all levels of management

• Good judgment and decision-making skills and capable of applying critical and analytical strategic thinking skills to manage complex/ambiguous situations

• Ability to plan for and integrate multiple tasks concurrently as well as work independently with minimal direction

• Ability to negotiate persuade and influence others including a cross-cultural awareness

• Strong understanding of the key principles of project management (time quality cost) including solid financial acumen

• Proactive solutions-oriented and adaptable to changing priorities and situations

• Advanced therapeutic area knowledge and clinical development guidelines and directives

Why Join Us
When you join Thermo Fisher Scientific you become part of a global team that values passion innovation and a commitment to scientific excellence. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.