DRT Strategies, Inc.
FDA IPS3 - SME II on FDA CDER OCD Project
Silver Spring, MD - Full Time
Overview
DRT Strategies delivers expert management consulting and information technology (IT) solutions to large federal agencies, the U.S. Navy, state and local government and commercial clients in health care, technology, and financial services industries.
The three letters of our name, DRT, stand for Driving Resolution Together, which is the core philosophy on which the company was founded. That is, we collaborate with our clients to solve their most pressing challenges - together.
We are problem solvers dedicated to your success, combining Fortune 500 experience with small business responsiveness. We have established a reputation with our clients as a forward-thinking consulting firm with demonstrated success in implementing solutions that lead to meaningful results. Our world-class consultants unite people to work collaboratively to achieve project goals and make vision a reality.
Project Description:
CDER’s Office of the Center Director (OCD) provides leadership and overall direction to all CDER activities to ensure that the mission of the Center is accomplished. Within OCD, the Controlled Substances Program/Controlled Substances Initiatives (CSP/CSI) team leads strategy and policy development for substances with abuse potential by helping to identify, mitigate, and manage emerging and ongoing issues to minimize risks associated with non-medical use and enable appropriate access to these products for medical use. CSP/CSI works closely with other CDER super offices, including the Office of New Drugs (OND), on activities such as safety labeling updates, guidance development, and external scientific engagement.
Job Summary:
The CSP/CSI team is seeking high-level task management support services to assist with
activities related to substance use and overdose prevention. In working with CSP/CSI, the
contractor will provide program management support to coordinate and manage work efforts across controlled substances initiatives and programs, as well as dedicated support for OND’s Division of Psychiatry and Division of Anesthesia, Addiction Medicine, and Pain Medicine.
Responsibilities:
DRT offers full-time benefit eligible employees a competitive total compensation package. Employees may begin participating in employer sponsored group medical, dental, and vision coverage on their first day of employment. DRT also has a 401(K)-retirement plan, company paid short-term and long-term disability, life insurance, AD&D coverage, and an employee assistant program (EAP). Employees may also elect critical illness coverage, accident coverage, flexible spending accounts, and health saving account options. The DRT leave programs include Paid Time Off (PTO) each calendar year, paid holidays annually, paid parental leave, and unpaid job protected leave administered in accordance with the Family Medical Leave Act (FMLA).
DRT Strategies delivers expert management consulting and information technology (IT) solutions to large federal agencies, the U.S. Navy, state and local government and commercial clients in health care, technology, and financial services industries.
The three letters of our name, DRT, stand for Driving Resolution Together, which is the core philosophy on which the company was founded. That is, we collaborate with our clients to solve their most pressing challenges - together.
We are problem solvers dedicated to your success, combining Fortune 500 experience with small business responsiveness. We have established a reputation with our clients as a forward-thinking consulting firm with demonstrated success in implementing solutions that lead to meaningful results. Our world-class consultants unite people to work collaboratively to achieve project goals and make vision a reality.
Project Description:
CDER’s Office of the Center Director (OCD) provides leadership and overall direction to all CDER activities to ensure that the mission of the Center is accomplished. Within OCD, the Controlled Substances Program/Controlled Substances Initiatives (CSP/CSI) team leads strategy and policy development for substances with abuse potential by helping to identify, mitigate, and manage emerging and ongoing issues to minimize risks associated with non-medical use and enable appropriate access to these products for medical use. CSP/CSI works closely with other CDER super offices, including the Office of New Drugs (OND), on activities such as safety labeling updates, guidance development, and external scientific engagement.
Job Summary:
The CSP/CSI team is seeking high-level task management support services to assist with
activities related to substance use and overdose prevention. In working with CSP/CSI, the
contractor will provide program management support to coordinate and manage work efforts across controlled substances initiatives and programs, as well as dedicated support for OND’s Division of Psychiatry and Division of Anesthesia, Addiction Medicine, and Pain Medicine.
Responsibilities:
- Must be able to work standard business hours synced with East Coast time zone.
- Serves as a senior advisor to customer’s executive management team in a variety of capacities.
- Key responsibilities include:
- Providing advice and expertise.
- Strategic planning and process improvement methods.
- Change enablement and management.
- Consolidation of operations.
- Scope, map, define, and track project phases, deliverables, key milestones, and evaluation criteria.
- Perform literature scanning/reviews and data analysis.
- Draft, edit, and manage clearance for documents under staff direction.
- Design, implement, and maintain a database or data repository (SharePoint site) as needed for projects.
- Assist with the development and implementation of stakeholder engagement strategies, including coordination meetings with partners internal and external to FDA.
- Draft and circulate meeting agendas and summaries for review, finalize them, and archive the final versions in SharePoint.
- Respond to staff inquiries and requests in a timely manner.
- Coordinate and facilitate meetings with the CSP/CSI SME and relevant workgroups.
- Formulate, communicate, and enforce quality work standards.
- Government experience is strongly preferred – working with FDA a plus.
- Responsible for identifying any potential program risks and for identifying them to the Government as soon as they are recognized.
- Responsible for ensuring deliverables are done correctly and delivered on time.
- Plans, supports, and provides advice/contributions in complex and critical efforts which include specific functional, technical, professional, or policy areas of the project.
- Scope, map, and define project phases, deliverables, key milestones, and evaluation criteria.
- Demonstrated experience designing and implementing digital solutions to track and document projects and workflows is required.
- Demonstrated experience designing, implementing, and maintaining databases and data repositories is required.
- A successful candidate must have experience as a subject matter expert.
- Demonstrated experience working directly with the client to provide expert guidance and advice is required.
- Conduct requirements gathering sessions with stakeholders.
- Perform searches in FDA archival systems; identify, curate, and organize documents as needed.
- Track and follow up on project assignments and actions, and monitor timeliness of all FDA commitments and deliverables to assist with staff accountability.
- Respond to staff inquiries and requests in a timely manner.
- Provide a monthly status report on all active tasks.
- Must have demonstrated experience working on complex projects and portfolios that include cross-team and cross-functional responsibilities.
- Minimum 10-15 years of experience is required.
- Ability to pass a US Public Trust background investigation for access to the client site and computing systems.
- Must be able to work standard business hours synced with East Coast time zone.
- Experience working with the FDA
- Bachelor’s degree required. Master’s preferred.
- Salary commensurate with experience.
DRT offers full-time benefit eligible employees a competitive total compensation package. Employees may begin participating in employer sponsored group medical, dental, and vision coverage on their first day of employment. DRT also has a 401(K)-retirement plan, company paid short-term and long-term disability, life insurance, AD&D coverage, and an employee assistant program (EAP). Employees may also elect critical illness coverage, accident coverage, flexible spending accounts, and health saving account options. The DRT leave programs include Paid Time Off (PTO) each calendar year, paid holidays annually, paid parental leave, and unpaid job protected leave administered in accordance with the Family Medical Leave Act (FMLA).
DRT Strategies, Inc. (DRT) follows the guidelines outlined by the Equal Employment Opportunity Commission (EEOC) to provide all employees and qualified applicants employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related conditions, transgender status, and sexual orientation), national origin, age, genetic information, disability, protected veteran status, or any other protected characteristic under federal, state, or local law.
Reasonable accommodations for applicants and employees with disabilities will be provided. If a reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact Human Resources by emailing HR@drtstrategies.com, or by dialing 571-482-2517.
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