DRT Strategies
Medical Editor - Mid
DRT Strategies, Silver Spring, Maryland, United States, 20900
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:
The project provides on-site medical editing support to the FDA Center for Biologics Evaluation and Research (CBER), particularly the Office of Vaccine Research and Review (OVRR). The project supports the FDA’s mission to ensure that safe and effective biologics are available to the American people.
What are we looking for?
The Medical Editor will edit and format reviews of marketing applications reviews, INDs, and Sponsor meetings as needed. The medical editor will work with a team of writers and editors to coordinate with FDA staff to work on OVRR's Integrated Review pilot. The position requires excellent organizational and communication skills, prior working knowledge of Integrated Review template and process, attention to detail, consistency, ability to manage tight deadlines, and frequent interaction with FDA stakeholders across several Offices and Divisions.
Fun stuff you will do on the job:
• Work with a team of editors and writers to manage document control, edit and format for consistency and one voice; work with FDA stakeholders in their review of complex scientific documents including reviews of new drug applications, policy documents, committee briefings, and slide presentations
• Perform copy editing for grammar, punctuation, style, and internal consistency
• Perform literature searches to assist with editing and revision of document content
• Perform routine quality checks on work done by fellow medical writers/editors
• Manage SharePoint site organization and updates
• Check document for Section 508 compliance
• Work with FDA stakeholders on establishing project requirements, scope, risks, and deliverables
• Oversee task order project management including financials and forecast
• Participate in management activities as defined by management team
• Assist with overall project support as needed
This is you:
• Prior experience in editing and formatting of user fee documents and/or scientific documents.
• Excellent organizational, time management, and communication skills. Ability to take meeting notes and synthesize into major discussion points; capture stakeholder discussions.
• Ability to independently manage a diverse portfolio of projects to complete work in a timely manner and meet mandatory deadlines despite frequent interruptions and shifting priorities
• Computer skills: MS Office, EndNote
• Intermediate experience and/or certification in Microsoft Word with willingness to learn advanced features
You will wow us even more if you have these skills:
• Experience editing guidelines or other policy documents for the federal government
• 2+ years of copy-editing experience and familiarity with a style guide (e.g., AP, Chicago, or AMA)
• Familiarity with SharePoint, EndNote, and Visual Basic
• Familiarity with Section 508 compliance
• Experience with federal communications
• Ability to understand and follow scientific discussion on drugs, clinical trials, adverse events, treatment effects, and product labeling
• Familiarity with FDA regulatory process
Education & Training:
• Bachelor’s or Master’s degree (STEM disciplines 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.
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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:
The project provides on-site medical editing support to the FDA Center for Biologics Evaluation and Research (CBER), particularly the Office of Vaccine Research and Review (OVRR). The project supports the FDA’s mission to ensure that safe and effective biologics are available to the American people.
What are we looking for?
The Medical Editor will edit and format reviews of marketing applications reviews, INDs, and Sponsor meetings as needed. The medical editor will work with a team of writers and editors to coordinate with FDA staff to work on OVRR's Integrated Review pilot. The position requires excellent organizational and communication skills, prior working knowledge of Integrated Review template and process, attention to detail, consistency, ability to manage tight deadlines, and frequent interaction with FDA stakeholders across several Offices and Divisions.
Fun stuff you will do on the job:
• Work with a team of editors and writers to manage document control, edit and format for consistency and one voice; work with FDA stakeholders in their review of complex scientific documents including reviews of new drug applications, policy documents, committee briefings, and slide presentations
• Perform copy editing for grammar, punctuation, style, and internal consistency
• Perform literature searches to assist with editing and revision of document content
• Perform routine quality checks on work done by fellow medical writers/editors
• Manage SharePoint site organization and updates
• Check document for Section 508 compliance
• Work with FDA stakeholders on establishing project requirements, scope, risks, and deliverables
• Oversee task order project management including financials and forecast
• Participate in management activities as defined by management team
• Assist with overall project support as needed
This is you:
• Prior experience in editing and formatting of user fee documents and/or scientific documents.
• Excellent organizational, time management, and communication skills. Ability to take meeting notes and synthesize into major discussion points; capture stakeholder discussions.
• Ability to independently manage a diverse portfolio of projects to complete work in a timely manner and meet mandatory deadlines despite frequent interruptions and shifting priorities
• Computer skills: MS Office, EndNote
• Intermediate experience and/or certification in Microsoft Word with willingness to learn advanced features
You will wow us even more if you have these skills:
• Experience editing guidelines or other policy documents for the federal government
• 2+ years of copy-editing experience and familiarity with a style guide (e.g., AP, Chicago, or AMA)
• Familiarity with SharePoint, EndNote, and Visual Basic
• Familiarity with Section 508 compliance
• Experience with federal communications
• Ability to understand and follow scientific discussion on drugs, clinical trials, adverse events, treatment effects, and product labeling
• Familiarity with FDA regulatory process
Education & Training:
• Bachelor’s or Master’s degree (STEM disciplines 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.
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