Global Regulatory Submissions Project Manager

MMS; Chicago (IL); In loco; USD 110.000 - 160.000; Tempo pieno

Descrizione del lavoro

MMS is a data-focused clinical research organization (CRO) with a Great Place to Work certification, seeking a seasoned project leader to drive regulatory submissions and strategic programs. You will partner with cross-functional teams to plan, execute, and monitor IND/NDA/MAA submissions, while managing budgets and client relationships across global projects.

Ideal candidates bring 5+ years in project coordination/management within pharmaceutical development, with strong communication and

Competenze

• Bachelor’s degree or equivalent with 5+ years in project coordination/management.
• Expert knowledge of pharmaceutical development phases; NDA/MAA filing preferred.
• Experience building integrated regulatory submission plans with timelines and risks.
• Strong organizational, communication, collaboration, and problem-solving skills.
• Experience managing project budgets, invoicing, profitability and utilization.
• Ability to lead multiple client engagements and global teams.

Mansioni

• Lead the planning and preparation of regulatory submissions (IND, NDA, MAA) with functional leads.
• Coordinate with cross-functional teams to identify dependencies and mitigate risks.
• Develop and maintain submission timelines, critical paths, and contingency plans.
• Oversee multiple client engagements and deliverables to meet deadlines.
• Lead project discussions, track progress, and report status and metrics to stakeholders.
• Manage budgets, invoicing, profitability, margins and resource utilization.
• Contribute to RFP scoping and communicate the company’s value in business discussions.
• Partner with clients to understand needs, evaluate options, and propose solutions.
• Identify opportunities to improve client satisfaction and relationships.
• Facilitate meetings with remote and global teams; drive collaboration and negotiations.
• Support process improvements in project management and collaboration.
• Promote open communication across remote and global teams.

Conoscenze

Regulatory submissions planning

Cross-functional collaboration

Project coordination/management

Budgeting and profitability

Communication and stakeholder mgmt

Remote/global team leadership

Formazione

Bachelor’s degree or equivalent

Descrizione del lavoro

MMS is a data-focused clinical research organization (CRO) with a Great Place to Work certification, seeking a seasoned project leader to drive regulatory submissions and strategic programs. You will partner with cross-functional teams to plan, execute, and monitor IND/NDA/MAA submissions, while managing budgets and client relationships across global projects.

Ideal candidates bring 5+ years in project coordination/management within pharmaceutical development, with strong communication and