Leidos Government Health and Safety Solutions Operations is seeking Regulatory Project Manager (PM) with experience in the FDA regulatory review processes and agile project management. The successful candidate will be responsible for the successful delivery of systems and electronic tools that streamline and automate workload management and regulatory review processes. This role has direct customer communication and is a point-of-contact to support application roadmap design and definition, perform risk management identification and mitigation, and development implementation timelines based on a tailored Agile DevSecOps environment.
Provide leadership, management and interpersonal communication skills necessary to successfully inspire, lead, direct and manage a cross functional delivery teams
Mentor the team in the FDA regulatory review process and ensure the team’s understanding of the stakeholder’s vision, objectives and goals
Expertly manage cross-functional teams responsible for delivering high-quality program capabilities on time and within budget, schedule and scope, including Subcontractors
Integrate the Contractor’s management and technical activities across the entire contractor staff to ensure they are consistent
Ensure that all work on this contract complies with the contract terms and conditions and is approved/coordinated with senior corporate managers
Serve as the primary interface and trusted advisor of the federal stakeholders and COR
Drive the development and implementation of innovation roadmap and strategy, with projected cost savings
Drive continuous service improvement and innovation.
Plan/lead program reviews and briefings, both internal and with the customer.
Manage and integrate the efforts of subcontractors, assuring flow-down and fulfillment of all contractual requirements in alignment with defined priorities.
Collaborate with related contracts to delivery effectively for the customer.
Develop business case justifications and cost/benefit analyses for IT spending and initiatives.
Lead staffing actions, including recruitment, supervision, development, evaluation and disciplinary actions.
Establish and maintain regular written and in-person communications with the organization’s executives, department heads and end users regarding pertinent IT activities.
Bachelor’s degree and more than seven years of experience related to IT project management
5+ years of experience supervising or leading Agile teams or projects within the HHS EPLC
3+ years of FDA regulatory review processes experience
Ability to collaborate with senior level customers and technical staff in forming strategies to improve performance, reliability, and cost effectiveness
Experience working in a fast paced, agile environment with competing priorities.
Ability to influence others outside of own area on policies, practices and procedures.
Demonstrated excellent written and oral communication skills, including experience in presenting material to senior Government officials and communicating and coordinating with other Government contractors and stakeholders
Ability to obtain a Public Trust Clearance
Experience with Oracle business process management (BPM) suite or low-code/no-code workflow tools
In order to enter Leidos facilities in the U.S. and to attend Leidos events outside our facilities, employees are required to be vaccinated for COVID-19 or maintain proof of a negative COVID-19 test within 96 hours of entry. In addition, we are receiving guidance from certain customers that onsite contractor personnel will need to be fully vaccinated to access customer facilities. If you are not vaccinated, please consider getting your COVID-19 vaccination as soon as possible. If you have any questions, please contact your Talent Acquisition POC.
Leidos is a Fortune 500® technology, engineering, and science solutions and services leader working to solve the world’s toughest challenges in the defense, intelligence, civil, and health markets. The company’s 44,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported annual revenues of approximately $13.7 billion for the fiscal year ended December 31, 2021. For more information, visit www.Leidos.com.
Pay and Benefits
Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here.
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Commitment to Diversity
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.