Medical Operations Director for Regulatory Excellence
1 week ago
Job Overview: As the Medical Operations Director for Regulatory Excellence at AE Strategies, you will play a pivotal role in formulating and executing operational strategies that drive innovation and excellence in drug evaluation and regulatory science.
About AE Strategies: Our organization operates in a fast-paced, highly regulated environment where precision and adherence to strict standards are paramount. We value scientific integrity, innovation, and public service, promoting a collaborative setting that thrives on transparency, accountability, and continuous improvement.
Responsibilities:
- Strategic Planning and Implementation: Lead the formulation and execution of our strategic directions, ensuring alignment with CDER and FDA priorities. Oversee the development and monitoring of short- and long-range organizational goals, analyzing workload and performance data to identify and address gaps.
- Operational Leadership and Performance Evaluation: Ensure our objectives and goals maintain alignment with regulatory obligations, providing executive-level reports on program performance and communicating strategic plans across the organization.
- Regulatory and Scientific Program Oversight: Provide expert leadership in regulatory and scientific review processes, ensuring consistency and efficiency across all sub-units. Represent our organization at internal and external meetings, offering scientific and regulatory guidance.
- Quality Management: Direct and oversee our quality management program, implementing and monitoring quality control systems to detect and correct non-conformances quickly. Promote a culture of continuous improvement, leading efforts to enhance processes and performance metrics.
- Stakeholder Collaboration and Change Management: Foster collaboration with other organizations and external stakeholders to ensure cohesive regulatory operations, leading change management initiatives and developing strategic initiatives requiring cross-functional collaboration.
Requirements:
- Degree: Bachelor's or graduate/higher level degree: major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position.
- Skills and Experience: Executive leadership experience with an established record of accomplishment in leading organizations of significant size and complexity. Effective communicator who can drive collaboration, empower staff, and is committed to the Public Health mission. Ability to manage and lead a diverse interdisciplinary staff, driving collaboration and empowering staff.
Salary Range: $120,000 - $180,000 per annum, depending on qualifications and experience. This competitive salary reflects the importance of this role in driving excellence in drug evaluation and regulatory science.
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