Scientific Regulatory SME

Clearance Level
Functional Experts
Remote, Based in USA
Home Office, Virginia

REQ#: RQ101798

Travel Required: None
Requisition Type: Regular

General Dynamics Information Technology is seeking a detail oriented, customer-focused, and motivated Product Delivery Manager/Regulatory SME with strong communication skills that is interested in becoming part of our FDA team supporting our customers with their critical mission needs. The Product Delivery Manager is a customer-facing role that works directly with some of our most distinguished customers, developing a product roadmap for modernization. You will work closely with stakeholders and other product management teams nurturing long-lasting relationships and exceeding customer expectations. You’ll be part of an agile delivery team, focused on providing high value features to our customers as they modernize both their processes and the IT implementation to support them. The individual will serve as the primary point of contact for the team, working closely with the FDA Product Owner and the larger integrated project team.

A typical day will include responsibilities in several areas -

Client Management:

  • Guide project meetings and other client engagements to meet customer expectations

  • Participate and lead customer-facing communication, reporting on sprint progress, burn down, velocity, and story points

  • Prepare and deliver frequent updates, maintaining positive customer relationships and ensuring a positive customer journey

  • Prepare status updates with key milestones and deliverables, next steps, risks, and project timeline

  • Manage timeline and scope ensuring customer expectations are met

  • Communicate difficult/sensitive information tactfully and resolve or escalate issues in a timely fashion

  • Understand and validates the details of deliverables as provided by project resources

Product Management:

  • Develop product roadmap with external stakeholders

  • Manage product development using agile best practices

  • Oversee analysis and documentation of customer’s business requirements and processes

  • Oversee planning and design of business processes; assist in formulating recommendations to improve and support business activities.

  • Assist in the research and assessment of business goals, objectives and needs to align information technology solutions with business initiatives

  • Participate in testing activities such as functional testing and user acceptance testing (UAT).

Team/Agile Management:

  • Work with the implementation team to develop releases plans and ensure product backlogs are well-groomed, prioritized and visible to all the stakeholders

  • Assist team to become self-organizing and self-managing to achieve its goals

  • Ensure the team’s “definition of done” is well defined on the story, sprint, and release levels

  • Be part of a continuous improvement mindset and recommend adjustments to established delivery practices

  • Participate in Scrum meetings to represent Product Owner and ensure cross-team collaboration and coordination of release plans

  • Communicate effectively with large and small project teams consisting of both technical and non-technical project stakeholders to set and manage client expectations and timelines throughout the project

  • Provide transparency to senior leadership and work with design, development, information security, and other product management teams

What You’ll Need

Required Skills and Experience:

  • Bachelor’s degree with 8+ years of experience (or equivalent combination of education and experience)

  • Experience with FDA customer, to include the drug development / regulatory approval process

  • Experience managing projects with multiple key stakeholders

  • Experience managing multi-system projects and self-organized, cross-functional project teams in a matrixed environment

  • Experience working in an scrum-agile environment

  • Familiar with Agile values, principles, processes, and methods such as iterative and incremental development, burn down, continuous integration, test-driven development (TDD), unit testing, code refactoring, pair programming, and/or Scrum ceremonies

  • Excellent power point and presentation skills

Desired Skills and Experience:

  • Knowledge of JIRA

  • PMP certification and Second level Scrum Master certification (CSP, SAFe Agilist, SAFe Practitioner)

  • 3+ years agile team facilitation experience (e.g. Scrum Master, Agile Facilitator etc.)

Attribute for Success:

  • Strong written and verbal communication skills

  • Energetic, goal oriented, proactive, innovative, hardworking, and patient

What GDIT Can Offer You:

  • Full-flex work week

  • 401K with company match

  • Internal mobility team dedicated to helping you own your career

  • Collaborative teams of highly motivated critical thinkers and innovators

  • Ability to make a real impact on the world around you

Not sure this job’s the one for you? Check out our other openings at

COVID-19 Vaccination Requirement: To protect the health and safety of its employees and to comply with customer requirements, GDIT may require employees in certain positions to be fully vaccinated against COVID-19. Vaccination requirements will depend on the status of the federal contractor mandate and customer site requirements.

The likely salary range for this position is $160,000 - $240,000, this is not, however, a guarantee of compensation or salary; rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range.

View information about benefits and our total rewards program.

We are GDIT. The people supporting some of the most complex government, defense, and intelligence projects across the country. We deliver. Bringing the expertise needed to understand and advance critical missions. We transform. Shifting the ways clients invest in, integrate, and innovate technology solutions. We ensure today is safe and tomorrow is smarter. We are there. On the ground, beside our clients, in the lab, and everywhere in between. Offering the technology transformations, strategy, and mission services needed to get the job done.

GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.