Medasource · 10 hours ago
Regulatory Oncology Program Manager
United States
Contract
Remote
Senior Level
5+ years expMedasource is seeking a Regulatory Program Manager to lead operational efforts in the Oncology portfolio. The RPM will drive projects by translating global regulatory strategy into executable plans while coordinating cross-functional team efforts to ensure alignment with program objectives.
Health CareMedical
Hiring Manager
Landan Chastain
Responsibilities
Empower teams to deliver the highest possible impact for our programs, business, and patients around the world
Translate regulatory requirements and strategy into an executable plan at a level of detail that allows teams to understand what is critical at any one time, proactively identify and mitigate risks, and exploit meaningful opportunities for acceleration. (e.g., MSP project plan, risk and opportunity playbooks, scenario evaluation and business case development)
Lead operations with Global Regulatory Team (GRT), including activities such as ensuring visibility to and/or management of worldwide submissions, driving processes to optimize global filing and launch strategy, pre- and post-submission activities, preparation for health authority meetings and additional major regulatory milestones
Provide strong operational leadership to Regulatory and program teams, providing scenario and visualization support driving rapid and informed decision making, challenging status quo, and fostering impactful innovation
Support the Global Regulatory Team (GRT) in a manner that fosters and maintains a high-performance team culture, facilitating GRT, Submission Working Group, Rapid Response Team meetings, and similar as required
Ensure coordination of critical regulatory information and team communications to ensure timely and accurate dissemination of the GRT strategy and operational status throughout the team including co-development partners and/or other external partners, as required. Liaise with Compound Development Team (CDT) and Senior Leadership Team (SLT) partners to prepare discussions and drive meeting outcomes
Lead the operational execution of select marketing applications including, clinical variations and Pediatric submissions, partnering to ensure alignment of Regulatory and compound submission strategies, developing clear and detailed plans, ensuring team roles, responsibilities and accountabilities, and positioning teams to proactively mitigate risks and enhance opportunities
Drive process improvements and embed best practices from across programs, TA’s and functions into supported teams
Work across functions and organizational boundaries to establish processes and procedures and new innovative methods that improve overall delivery
Build RPM value proposition through continuous refinement of delivery, prioritizing and focusing on areas of highest impact and opportunity, and actively leading efforts to enable enhanced capabilities and impacts
Serve as a mentor and coach to other RPMs and team members
As required, work with standard budgeting and forecasting process and reporting tools to build and maintain the regulatory components and health authority budget to an overall coordinated project plan in Planisware
Support and facilitate activity, resource and cost planning across the R&D project portfolio, as required
Qualification
Required
A minimum of a Bachelor's degree is required, preferably in Life Sciences, Business Management, Regulatory Affairs, or a related discipline. Advanced degree preferred
Proficient knowledge of MS Project (MSP)
A minimum of 5 years of industry/business experience is required
A minimum of 3 years of experience in a Pharmaceutical, MedTech or comparable R&D area is required
Experience in strategic planning and development of global regulatory strategy, and cross functional management of global regulatory submissions and processes (e.g., NDA, MAA, and lifecycle documents) is required
Demonstrated understanding of Global Regulatory Affairs processes is required
Project management experience leading global regulatory teams in a matrix setting is required
Demonstrated experience conducting business process, scenario, and critical path analysis is required
Knowledge of global regulations, guidelines and regulatory requirements is required
Proficiency and demonstrated application of project management standards, planning and visualization tools is required
Must have excellent verbal and written communication skills
Must have strong innovative and strategic thinking skills
The ability to drive and expedite team decision-making and translate strategy to clear, executable action plans is required
The ability to resolve controversy and influence teams without formal authority is required
The ability to influence decision-making at all levels and represent project teams with senior leadership and governance bodies is required
Preferred
Experience leading submission teams and working with external partners is preferred
Project management certification preferred
Regulatory certification (RAC) preferred
High proficiency in reporting tools and experience in report development is highly preferred
High proficiency with Microsoft Project in server and/or online environment is highly preferred
Company
Medasource
Medasource is a hospital & health care company specializing in population health management and clinical engineering services.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Abimbola ojo
EPIC OPTIME/ ANESTHESIA Consultant at Ascension
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