Job Description
Are you looking to join a company where your contributions truly matter, and where you’ll be part of a supportive, innovative team? MMS is an award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work® Certified organization, recognized for our exceptional culture and industry-leading employee retention. We support the pharmaceutical, biotech, and medical device industries with our proven scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.
Core Responsibilities
- Lead the planning and preparation of IND, NDA, and MAA submissions to applicable 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 operational strategies to meet submission 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, 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, risk, and performance updates to key stakeholders.
- Manage project budgets, revenue recognition, timely invoicing, profitability, margins and utilization.
- Contribute to RFP scoping and costing efforts and clearly communicate the company’s value proposition in written and verbal business development 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, and promote efficient collaboration.
- Support continuous improvement by identifying opportunities to enhance project processes, collaboration, and outcomes.
- Promote open communication and effective collaboration across remote and global teams.
Requirements
- Bachelor’s degree or equivalent relevant experience, with at least 5 years of project coordination, project management, or related experience.
- Expert knowledge of pharmaceutical development phases and NDA structure; NDA and MAA filing experience strongly preferred.
- Demonstrated experience developing and managing 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 and take appropriate action.
- Demonstrated ability to manage multiple client engagements and concurrent deliverables while prioritizing a high-volume, complex workload.
- Demonstrated 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.
