Project Manager, REMS Team - Remote based in the US

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 You'll 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:

• Bachelor's 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