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
This project will support the Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Quality Surveillance with Enhancing the semi-automated site dossier process.
Job Summary
The objective of this project is to conduct thorough research and implement efficient methods for ingesting publicly available foreign regulatory data. This includes reviewing and evaluating a list of publicly available information, identifying other potential public data sources, developing robust methods for data extraction, and ensuring accurate matching with the correct facility or other identifiers such that the extracted information can be merged with existing FDA data. The pipeline will be designed for continuous ingestion on a daily basis, with a focus on long-term sustainability.
Additionally, the project aims to extract valuable insights from the acquired and existing data by employing advanced techniques such as time-series analysis, trend analysis, and machine learning (including clustering, natural language processing, and outlier identification). These techniques are intended to maximize the value derived from the available data, foster a proactive approach, and effectively identify high-risk facilities. This project would provide contractor support for data extraction and analytics that are needed to enhance our dossier program.
Responsibilities
- Utilize extensive expertise in Python for automation. Familiarity with databricks and utilize data mining techniques and web scraping tools to extract valuable insights and information from various sources, such as websites and databases.
- Apply experience with business intelligence, analytics, reporting, and data transformation skills to drive insights.
- Apply knowledge and experience in analytics and statistics to analyze and interpret the data effectively.
- Apply knowledge of data types, formats, data architecture, and pipeline optimization techniques to effectively manage and process data.
- Technical strategy: Demonstrate analytical capabilities and critical thinking skills and ability to identify new issues, trends, and opportunities from data.
- Operational Excellence: Ensure the reliability, efficiency, and quality of data services and pipelines.
- Perform hands-on work with data analysis, validation, and quality assurance.
- Prepares and delivers presentations.
- Researches and identifies root cause/data issues. Ensure timely delivery of reports and manage conflicting priorities and customer expectations.
- Performs periodic check-ins for status and feedback. Identifies gaps in the system and communicate them to the solution project leads/program manager.
- Documents the unmet data needs of stakeholders for reporting purposes. Collaborate
With Cross-functional Teams.Require Experience
- Minimum 5 years of experience in at least one of the following work areas: analytics, biopharmaceutical manufacturing, quality analytics, biotechnology research and development, or other area relevant research programs.
Preferred Experience:
- Experience and/or knowledge of analytical software used for data analysis
- Working experience at FDA and/or other HHS agencies
- Familiarity with FDA regulatory process
Education & Training:
- MS in a qualitative technical field such as computer science, engineering, statistics, or related field.
Salary Range:
- $90,000-$120,000
- Salary commensurate with experience.
Company Benefits:
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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