Senior Project Manager - Regulatory Submissions Planning (Remote)

Company: MMS
Location: Canton
Posted on: March 14, 2023

Job Description:

MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, including clinical trial transparency, -and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in -Global Health & Pharma's -international awards programs for the last three consecutive years. For more information, visit or follow MMS on .Position Description:Project Management

• Collaborate with functional leads for the preparation and submission of IND/CTAs and NDA/MAAs to global regulatory authorities
• Work with members of a cross-functional clinical team including data management, biometrics, regulatory writing, regulatory affairs and regulatory operations to identify and mitigate project risks; -revising operational strategies as appropriate to meet key project deadlines
• Create detailed project timelines for submissions with an understanding of dependencies and critical path analyses
• Identify resource needs including contingency plans for critical project tasks
• Manage day-to-day operational aspects of complex projects; - liaise with specialty vendors and other team members responsible for CMC and non-clinical components of a submission
• Lead discussions to gain team consensus in order to progress the project
• Provide project metrics and status reporting to key stakeholders
• Understanding and implementation of inspection readiness procedures; may facilitate/ guide sponsor team in their preparations
• Keep current with industry trends and best practices, global regulations, and other related topics
• Responsible for leading Governance meetings and overall asset advancement, adhering to defined plan(s)Project Accounting
  • Track and report team hours and expenses on a weekly basis
  • Manage project budget
  • Determine appropriate revenue recognition, ensure timely and accurate invoicing, and monitor receivables for project
  • Follow up with clients, when necessary, regarding unpaid invoices
  • Analyze project profitability, revenue, margins, bill rates and utilizationClient Management
    • Serve as primary contact with customers ensuring customer satisfaction, quality and consistency of operational performance
    • Responsible for initiating customer feedback and responding to feedback
    • Manage day-to-day client interaction
    • Set and manage client expectations
    • Develop lasting relationships with client personnel that foster client ties
    • Communicate effectively with clients to identify needs and evaluate alternative business solutions
    • Seek opportunities to increase customer satisfaction and deepen client relationships
    • Build a knowledge base of each client's business, organization and objectivesFinancial and Contract Management
      • Lead contract and budget negotiation efforts
      • Track financial status of assigned projects;
      • Understand and apply pricing models within budgets and comply with billing procedures
      • Assure project legal documents are completed and signedBusiness Development
        • Lead RFP efforts including completing project scoping and costing estimates; Effectively convey our message in both written and verbal business development discussionsCommunication
          • Facilitate team and client meetings effectively with remote and global based teams
          • Keep project team well informed of changes within the organization and general corporate news
          • Clear communicator and the ability to negotiateRequirements:Technical Understanding/ Training -
            • Bachelor's Degree required
            • Years of experience required: 3 plus yrs experience in pharmaceutical or healthcare industry
            • Specific experience preferred: 3 years -of Project Management experience -in -a pharmaceutical CRO services company
            • NDA/ MAA filing experience -required
            • Maintains awareness of new and emerging technologies and the potential application on client engagementsTeamwork
              • Consistently acknowledges and appreciates each team member's contributions
              • Effectively utilizes each team member to his/her fullest potential
              • Motivates team to work together in the most efficient manner
              • Keeps track of lessons learned and shares those lessons with team member
              • Mitigates team conflict and communication problemsPowered by JazzHR

Keywords: MMS, Canton , Senior Project Manager - Regulatory Submissions Planning (Remote), Executive , Canton, Michigan