Medical Operations Director for Regulatory Excellence

1 week ago


Silver Spring, Maryland, United States AE Strategies Full time

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.



  • Silver Spring, Maryland, United States AE Strategies Full time

    The Deputy Super Office Director for Operations at the Office of New Drugs, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA)Leadership Role: The successful candidate will share responsibility with the Super Office Director to formulate and set operational strategies.Key Responsibilities:Provide executive-level...


  • Silver Spring, Maryland, United States Sparks Group Full time

    About the RoleWe are seeking a highly skilled Administrative Director to oversee and manage daily operations within a specialized administrative unit at Sparks Group, partnered with a leading research institution.ResponsibilitiesManage and supervise a team of administrative professionals.Develop and implement efficient procedures to ensure adherence to...


  • Silver Spring, Maryland, United States Riderwood Village by Erickson Senior Living Full time

    About Riderwood VillageRiderwood Village by Erickson Senior Living is a leading provider of senior living and health care services. Our mission is to help people live better lives by fulfilling our promises of a vibrant lifestyle, financial stability, and focused health and well-being services.Job DescriptionWe are seeking a highly experienced Senior...


  • Silver Spring, Maryland, United States Compass Group USA Full time

    Crothall Healthcare is a leading provider of specialized support services to the healthcare industry. Salary: $70,000 per year.Other Forms of Compensation: End of year bonusPay Grade: 13Job DescriptionThe Director of Operations, Housekeeping Department will be responsible for assisting the Director of Environmental Services in directing and overseeing the...


  • Silver Spring, Maryland, United States Siemens Corporation Full time

    We are seeking a highly skilled Antitrust and Regulatory Expert to join our U.S. Legal team in the NYC or Washington, DC area.About the Role:This position focuses on U.S. antitrust law and regulatory matters, providing strategic advice on complex transactions and supporting cross-border M&A.You will be responsible for U.S. antitrust law, international trade,...

  • Medical Director

    1 day ago


    Silver Spring, Maryland, United States Riderwood Village by Erickson Senior Living Full time

    Seeking a Medical Director for Our Geriatric PracticeWe are hiring a highly skilled Medical Director to lead our geriatric practice at Riderwood Village by Erickson Senior Living.Compensation: $210,000 - $265,000 per year (includes base salary, bonus, and incentive)About the Role:The ideal candidate will have a medical degree from an accredited program,...


  • Silver Spring, Maryland, United States AE Strategies Full time

    Job DescriptionAt AE Strategies, we are seeking a highly skilled Regulatory Affairs Specialist to join our team.About the RoleThis is an exciting opportunity for a medical professional with expertise in pharmaceutical science to ensure the safety and effectiveness of human drugs manufactured for interstate sale. You will be responsible for ensuring that all...


  • Silver Spring, Maryland, United States AE Strategies Full time

    AE Strategies is seeking a skilled medical professional to oversee regulatory compliance and pharmaceutical expertise. With this role, you will be responsible for ensuring the safety and effectiveness of various products, including human drugs, vaccines, blood products, and medical devices.About the RoleThis position requires a strong understanding of...

  • Operations Director

    6 days ago


    Silver Spring, Maryland, United States McDonald's Restaurants Full time

    **About the Role**We are seeking a highly skilled and motivated General Manager to lead our restaurant team. As an Operations Director, you will be responsible for overseeing daily operations, managing staff, and ensuring excellent customer service.**Competitive Compensation Package**The salary range for this position is estimated to be between $69,890 and...


  • Silver Spring, Maryland, United States Premier Medical Staffing Full time

    Premier Medical Staffing is seeking a skilled Medical Imaging Specialist to join their team in Silver Spring, Maryland. This 13-week contract position offers an excellent opportunity for healthcare professionals to gain valuable experience and advance their careers.About the JobSpecialty: Interventional Radiology TechnologistDiscipline: Allied Health...


  • Silver Spring, Maryland, United States Trinity Health FirstChoice Full time

    Explore a challenging opportunity with Trinity Health FirstChoice as a travel nursing director RN case manager. Based in Silver Spring, Maryland, this 13-week assignment offers a competitive salary of $3200 per week, including travel reimbursement.About the RoleThis position requires exceptional leadership skills, with a minimum of 10 years of experience in...


  • Silver Spring, Maryland, United States Bel Pre Healthcare Center Full time

    Bel Pre Healthcare Center OpportunityWe are seeking a skilled Registered Nurse to assume the role of Director of Nursing Services at Bel Pre Healthcare Center, part of the CommuniCare Family of Companies. As a dedicated leader, you will oversee the nursing team and drive high-quality patient care.About UsA family-owned company with over three decades of...

  • Payroll Director

    5 days ago


    Silver Spring, Maryland, United States Children's National Health System Full time

    Job SummaryThe Payroll Director at Children's National Health System will oversee payroll operations, ensuring timely and accurate production and distribution of paychecks. The ideal candidate will have a strong background in finance, accounting, and business administration.


  • Silver Spring, Maryland, United States AE Strategies Full time

    Position Overview:The Office Director Information Technologist at AE Strategies provides strategic leadership for the organization and vision for continuing innovation and maintenance of center-specific IT. This individual leads in the development of projects and programs to support and ensure alignment with Center-specific IT, business services, and data...


  • Silver Spring, Maryland, United States Children's National Health System Full time

    Job OverviewChildren's National Health System seeks a Program Director for Organizational Wellbeing to lead the development and implementation of wellbeing initiatives that promote employee health and productivity. The ideal candidate will have experience in designing and implementing wellbeing programs, as well as strong leadership and project management...


  • Silver Spring, Maryland, United States Adventist HealthCare Full time

    About UsAdventist HealthCare, a faith-based organization with over a century of caring for the communities in Maryland, has earned a reputation for high-quality, compassionate care. As the largest healthcare provider in Montgomery County, we are dedicated to extending God's care through physical, mental, and spiritual healing.Salary InformationThe estimated...


  • Silver Spring, Maryland, United States Adventist HealthCare Full time

    At Adventist HealthCare, we are dedicated to delivering high-quality patient care in a compassionate and respectful manner. As a Medical Services Manager, you will play a vital role in ensuring the delivery of exceptional patient care while promoting a positive and professional work environment.Job SummaryWe are seeking an experienced Medical Services...

  • Head Chef

    6 days ago


    Silver Spring, Maryland, United States Riderwood Village by Erickson Senior Living Full time

    Riderwood Village by Erickson Senior Living offers a dynamic opportunity for an experienced Head Chef - Culinary Director to lead our culinary team and drive the success of our Signature Menu Dining Programs.OverviewWe are part of a growing national network of communities managed by Erickson Senior Living, one of the country's largest and most respected...


  • Silver Spring, Maryland, United States Regency Care of Silver Spring Full time

    Job OverviewAt Regency Care of Silver Spring, we are seeking a highly skilled and experienced individual to fill the role of Assistant Director of Nursing (ADON)/Infection Preventionist. This is a full-time management position with a competitive salary.Salary InformationThe selected candidate will receive an annual salary of $120,000, paid biweekly. In...


  • Silver Spring, Maryland, United States Sparks Group Full time

    Job OverviewSparks Group is partnering with a leading healthcare research institute to hire an experienced Accounts Payable Manager to oversee the day-to-day operations of the Accounts Payable department. This role requires strong leadership skills and expertise in managing financial processes, vendor relationships, and implementing efficient AP procedures.