Senior Project Manager, Regulatory Submissions

MMS; Denver (CO); Teletrabalho; USD 110 000 - 160 000; Tempo integral

Resumo da oferta

MMS Holdings Inc. seeks a highly organized Regulatory Submissions Lead to coordinate IND, NDA, and MAA filings and manage cross-functional teams across global sites.

You will partner with clinical, biometrics, regulatory writing, and regulatory operations to meet submission timelines, monitor budgets, and provide clear status updates to stakeholders while promoting efficient collaboration across remote and global teams.

Qualificações

• Bachelor’s degree or equivalent; at least 5 years in project coordination or project management.
• Expert knowledge of pharmaceutical development phases and NDA structure; NDA and MAA filing experience strongly preferred.
• Demonstrated ability to develop and manage integrated regulatory submission plans, including timelines, dependencies, critical paths, risks, resource needs, and contingency plans.
• Strong organizational, communication, collaboration, and problem-solving skills, with the ability to understand stakeholder needs and develop practical solutions.
• Experience managing project budgets, invoicing, profitability, margins, and utilization, with the ability to analyze financial performance.
• Demonstrated ability to manage multiple client engagements and concurrent deliverables while prioritizing a high-volume, complex workload.
• Experience leading client-facing discussions and collaborating effectively with remote, global, and cross-functional teams.
• Working knowledge of CRO operations and the drug development process.

Responsabilidades

• Lead the planning and preparation of IND, NDA, and MAA submissions to regulatory authorities in partnership with functional leads.
• Partner with cross-functional clinical, biometrics, regulatory writing, regulatory affairs, and regulatory operations teams to identify dependencies, mitigate risks, and adjust strategies to meet deadlines.
• Develop and maintain detailed submission timelines, including dependencies, critical paths, resource needs, and contingency plans.
• Oversee multiple client engagements and concurrent deliverables, prioritizing a high-volume, complex workload to meet submission deadlines.
• Lead project discussions, build team consensus, track progress, and provide clear project metrics and status updates to stakeholders.
• Manage project budgets, revenue recognition, invoicing, profitability, margins and utilization.
• Contribute to RFP scoping and costing efforts and clearly communicate the company’s value proposition in business discussions.
• Partner with clients to understand their needs, evaluate options, and recommend practical business solutions.
• Identify opportunities to improve customer satisfaction and strengthen long-term client relationships.
• Facilitate effective meetings with remote and global teams, communicate changes clearly, negotiate constructively, resolve conflicts.
• Support continuous improvement by identifying opportunities to enhance project processes and outcomes.
• Promote open communication and effective collaboration across remote and global teams.

Descrição da oferta de emprego

MMS Holdings Inc. seeks a highly organized Regulatory Submissions Lead to coordinate IND, NDA, and MAA filings and manage cross-functional teams across global sites.

You will partner with clinical, biometrics, regulatory writing, and regulatory operations to meet submission timelines, monitor budgets, and provide clear status updates to stakeholders while promoting efficient collaboration across remote and global teams.