Job Description
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.
What you will be supporting: DRT Strategies is seeking to fill a Policy Analyst position in the DC Metro Area to support FDA Center for Drugs Evaluation and Research (CDER) offices on new drug applications and abbreviated new drug applications.
What are we looking for? Policy Analyst will support scientists at the U.S. Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER), so that affordable generic drugs are available to the American public. The position requires the ability to work with FDA leadership on drug applications and policy documents, working proficiency with Microsoft Office and SharePoint, a willingness to stay current with regulatory standards and guidelines, and the ability to excel in a customer-focused environment. Preferred candidates will have education or experience in a scientific or healthcare field.
Fun stuff you will do on the job: As a Policy Analyst your responsibilities will include but are not limited to the following:
• Analyzing drug applications for regulatory compliance
• Identifying and analyzing labeling errors in drug applications
• Drafting and/or editing SOPs, SOPPs, and/or other policy documents.
• Supporting document categorization as per FDA requirement.
• Recognizing and correcting inconsistent use of scientific terms tables.
• Communicating efficiently and effectively with FDA scientists regarding requirements and timelines for projects.
• Performing routine quality checks on work performed by coworkers.
• Creating and maintaining internal documents such as process documents and training materials.
This is you: • 3+ years of related experience required.
• Degree in a Scientific or Health Field.
• Prior FDA or regulatory experience.
You will wow us even more if you have these skills: • Experience with the FDA and/or pharmaceutical industry.
• Savvy with Microsoft Word features.
• Experience in a regulatory, healthcare, laboratory, or pharmaceutical industry.
• Familiarity with Section 508 compliance.
Education & Training: Degree in a Scientific or Health Field preferred
DRT’s culture is reflective of our core values:
- Professionalism: Be a leader and someone your customers and colleagues can count on by taking ownership and accountability for your work. Demonstrate a solution-oriented mindset and bias for action. Show empathy, dignity, and respect for each other. Be "high minded", maintain a calm demeanor when dealing with ambiguity or adversity and stay out of the fray (i.e., avoid drama).
- Quality: Do things right and do the right thing. Pursue excellence in your work by delivering quality services and products that provide high value and return on investment (ROI).
- Teamwork: Work with each other, the customer, and DRT. Demonstrate flexibility, a positive attitude and willingness to work collaboratively to help others and share information.
- Customer Mission Focused: Commit to customer success and strive to exceed expectations by understanding the mission, executing the customer's vision, and solving challenges to drive results and achieve mission goals. Build meaningful customer relationships by asking thoughtful questions, listening, and operating transparently.
- Growth Mindedness: Commit to company, team, and personal growth. Embrace an entrepreneurial spirit by actively seeking opportunities to support new customer projects and/or solve problems. Actively work to improve your skills, learn to be comfortable with ambiguity, and be resourceful and willing to figure things out and add value.
Our culture fosters teamwork and transparency, empowering you to do great work. Our talented employees drive the success of the company – so our leadership is devoted to your success. We respect you as an individual. We recognize your contributions. We invest in your professional growth. Join us and let's continue to build your career together.
Currently due to the remote working status of the federal government, most DRT employees are teleworking from home and leveraging video conferencing along with other virtual productivity tools. Under normal circumstances, most of our positions are required to report onsite. However, DRT has not yet determined when employees will be required to return to their onsite workspaces. Please be aware that at the time a date is determined to return to the worksite, the requirement of this position may be to report in person to the work location.
DRT Strategies, Inc. (DRT) celebrates diversity and is proud to provide Equal Employment Opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetics, disability, or protected veteran status. In addition to federal law requirements, DRT complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities.
Job Tags
Full time, Local area, Remote job,