Global Regulatory Submissions PM — Clinical Trials

MMS; Seattle (WA); Presencial; USD 120 000 - 180 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health insurance

Resumo da oferta

MMS, a data-focused clinical research organization, seeks a seasoned Project Manager to lead regulatory submissions (IND/NDA/MAA) in collaboration with clinical, regulatory, and operations teams. You will drive timelines, dependencies, and risk mitigation for complex plans.

Responsibilities include leading client engagements, managing budgets and invoicing, and delivering clear status updates to stakeholders across remote and global teams. Seattle-based on-site role.

Qualificações

• Bachelor’s degree or equivalent relevant experience.
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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 for critical tasks.
• Oversee multiple client engagements and concurrent deliverables to meet submission deadlines.
• Lead project discussions, build team consensus, track progress, and provide status updates to key stakeholders.
• Manage project budgets, revenue recognition, invoicing, profitability, margins and utilization.
• Contribute to RFP scoping and costing efforts and communicate the company’s value in business discussions.
• Partner with clients to understand needs, evaluate options, and recommend practical business solutions.
• Identify opportunities to improve customer satisfaction and strengthen client relationships.
• Facilitate meetings with remote and global teams, communicate changes clearly, negotiate, resolve conflicts, and promote efficient collaboration.
• Support continuous improvement by identifying opportunities to enhance project processes, collaboration, and outcomes.

Conhecimentos

Regulatory submissions planning

Cross-functional coordination

Project management

Budget management

Effective communication

Regulatory knowledge

Formação académica

Bachelor's degree or equivalent

Descrição da oferta de emprego

MMS, a data-focused clinical research organization, seeks a seasoned Project Manager to lead regulatory submissions (IND/NDA/MAA) in collaboration with clinical, regulatory, and operations teams. You will drive timelines, dependencies, and risk mitigation for complex plans.

Responsibilities include leading client engagements, managing budgets and invoicing, and delivering clear status updates to stakeholders across remote and global teams. Seattle-based on-site role.