Current jobs related to Biologics Review Editor - Silver Spring, Maryland - DRT Strategies, Inc.
-
Senior Editor and Document Production Specialist
1 month ago
Silver Spring, Maryland, United States Panagora Group LLC Full timeAbout the RolePanagora Group LLC is seeking a highly skilled and experienced Senior Editor and Document Production Specialist to join our team. As a key member of our Corporate Communications department, you will play a critical role in supporting the production of high-quality documents, proposals, and other corporate materials.Key...
-
Regulatory Review Physician
4 weeks ago
Silver Spring, Maryland, United States AE Strategies Full timeJoin Our Team as a Clinical Trial ReviewerAbout the Role:We are seeking a highly skilled Clinical Trial Reviewer to join our team at the FDA. As a Clinical Trial Reviewer, you will play a critical role in ensuring the safety and efficacy of new drugs and biologics.Responsibilities:Review clinical trial protocols and study reports to ensure compliance with...
-
Silver Spring, Maryland, United States CAMRIS International Full timeJob SummaryWe are seeking a highly skilled Senior Biologics Process Development Scientist to support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland. The ideal candidate will have expertise in developing clonal cell lines, including mammalian cells, and experience with cell line...
-
Silver Spring, Maryland, United States CAMRIS Full timeWe are seeking a highly skilled Biologics Process Development Scientist to support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland. The PBF is a cutting-edge cGMP-compliant pharmaceutical manufacturing facility that engages in next-generation development for innovative companies and...
-
FDA Physician
4 weeks ago
Silver Spring, Maryland, United States AE Strategies Full timeJob Title: FDA Physician - Urologist Clinical Trial ReviewerAE Strategies is proud to partner with the FDA to recruit a skilled Clinical Trial Reviewer for their team. As a full-time physician position, this role requires a strong understanding of clinical and scientific knowledge to review new drugs and ensure their safety and effectiveness.About the...
-
FDA Physician
4 weeks ago
Silver Spring, Maryland, United States AE Strategies Full timeAbout the RoleAs a Clinical Trial Reviewer with the FDA, you will play a critical role in ensuring the safety and efficacy of new drugs. This is a unique opportunity to apply your clinical and scientific knowledge to complex medical problems and make a meaningful impact on public health.ResponsibilitiesReview new drugs to ensure they meet safety and efficacy...
-
Medical Technologist I
3 weeks ago
Silver Spring, Maryland, United States Trinity Health Full timeJob Title: Medical Technologist IWe are seeking a highly skilled Medical Technologist I to join our team at Holy Cross Health. As a Medical Technologist I, you will be responsible for performing routine and specialized procedures, reviewing and approving clinical test results, and supporting the Mission of Trinity Health.Responsibilities:Perform routine and...
-
Clinical Laboratory Scientist
4 weeks ago
Silver Spring, Maryland, United States Food and Drug Administration Full timeJob SummaryThis position is located in the Food and Drug Administration (FDA), Center of Biologics Evaluation and Research Center (CBER), Office of Blood Research and Review (OBRR), Division of Blood Components and Devices (DBCD), Devices Review Branch (DRB). The selected candidate will serve as a senior level reviewer of data in scientific specialty field...
-
SharePoint Developer
2 days ago
Silver Spring, Maryland, United States All Native Group Full timeJob Title: SharePoint DeveloperJob Summary:All Native Group is seeking a skilled SharePoint Developer to support our team in Silver Spring, MD. As a SharePoint Developer, you will apply current graphics design and .NET technologies to develop, modify, maintain SharePoint server portals. Your primary responsibility will be to serve as the primary SharePoint...
-
Medical Laboratory Specialist
3 days ago
Silver Spring, Maryland, United States Trinity Health Full timeJob Summary:Trinity Health is seeking a skilled Medical Technologist II to join our team. As a Medical Technologist II, you will be responsible for performing routine and specialized procedures, reviewing and approving clinical test results, and ensuring the quality of laboratory testing. You will work with infectious and hazardous substances, perform...
-
Technical Specialist, Document Production
7 days ago
Silver Spring, Maryland, United States Panagora Group Full timeJob DescriptionPanagora Group is a dynamic woman- and employee-owned small business and social enterprise dedicated to providing high-quality, high-impact international health, development, and learning services.We are seeking a highly skilled Technical Specialist, Document Production to support document production for proposals, deliverables, and other...
-
Medical Technologist II
2 weeks ago
Silver Spring, Maryland, United States Holy Cross Health Full timeJob Title: Medical Technologist II - Blood BankEmployment Type: Full-timeShift: Nights (10:30 p.m. - 7:00 a.m.) or Evenings (2:30 p.m. - 11:00 p.m.)Department: Blood BankLocation: Silver Spring, MDPosition Highlights:Competitive salaryBenefits – Medical, Dental & Vision, PTO, Free Parking, Metro Access, Tuition Reimbursement, 403(b)Quality of Life:...
-
Medical Laboratory Specialist
4 weeks ago
Silver Spring, Maryland, United States Holy Cross Health Full timeJob Title: Medical Technologist II - Blood BankEmployment Type: Full-timeShift: Nights (10:30 p.m. - 7:00 a.m.) or Evenings (2:30 p.m. - 11:00 p.m.)Department: Blood BankLocation: Silver Spring, MDHighlights:Competitive Salary: $32.12 - $48.18 per hourBenefits: Medical, Dental & Vision, PTO, Free Parking, Metro Access, Tuition Reimbursement, 403(b)Quality of...
-
Gene Therapy Vector Researcher
1 day ago
Silver Spring, Maryland, United States Kikiktagruk Inupiat Corporation Full timeJob SummaryMidnight Sun Technologies is seeking a highly skilled Gene Therapy Vector Researcher to support a Federal contract with the FDA. This position will contribute to the research program of the FDA's Center for Biologics Evaluation and Research (CBER), Office of Tissue and Advanced Therapies, Division of Cellular and Gene Therapies.Key...
-
Medical Laboratory Specialist
2 weeks ago
Silver Spring, Maryland, United States Trinity Health Full timeJob Title: Medical Technologist IWe are seeking a highly skilled Medical Technologist I to join our team at Holy Cross Health. As a Medical Technologist I, you will play a critical role in providing high-quality laboratory services to our patients.Responsibilities:Perform routine and specialized laboratory procedures, including blood banking, chemistry,...
-
Medical Laboratory Specialist
3 weeks ago
Silver Spring, Maryland, United States Trinity Health Full timeJob Title: Medical Technologist IJob Summary:We are seeking a highly skilled Medical Technologist I to join our team at Holy Cross Health. As a Medical Technologist I, you will be responsible for performing routine and specialized procedures, reviewing and approving clinical test results, and supporting the mission of Trinity Health.Responsibilities:Perform...
-
Medical Technologist I
3 weeks ago
Silver Spring, Maryland, United States Trinity Health Full timeJob Title: Medical Technologist IJoin our team of dedicated professionals at Holy Cross Health, a Catholic, not-for-profit health system serving over 240,000 individuals annually in Maryland's Montgomery and Prince George's counties.Job Summary:We are seeking a highly skilled Medical Technologist I to join our laboratory team. As a Medical Technologist I,...
-
Deputy Super Office Director for Operations
2 days ago
Silver Spring, Maryland, United States AE Strategies Full timeThe Deputy Super Office Director for Operations at the Office of New Drugs, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), plays a pivotal role in shaping the office's operational strategies. This executive-level position oversees regulatory operations, strategic planning, program effectiveness, and quality...
-
Deputy Super Office Director for Operations
2 weeks ago
Silver Spring, Maryland, United States AE Strategies Full timeJob Title: Deputy Super Office Director for OperationsJoin AE Strategies as we seek an experienced executive leader to fill the role of Deputy Super Office Director for Operations. This position offers a unique opportunity to impact public health on a national scale by leading operations across the FDA's Center for Drug Evaluation and Research.Job...
-
Research Policy Analyst
4 weeks ago
Silver Spring, Maryland, United States FedWriters Full timeResearch Policy Analyst Job DescriptionOverview:We are seeking a highly skilled Research Policy Analyst to support the NOAA Weather Program Office (WPO) in providing policy and research services for the National Weather Service. As a key member of our team, you will contribute to advancing weather research, which is crucial for saving lives, reducing...
Biologics Review Editor
2 months ago
DRT Strategies, Inc. is a leading provider of management consulting and IT solutions tailored for federal agencies, particularly in the healthcare sector. Our mission is to collaborate with clients to address their most critical challenges through innovative solutions.
Project Support:
The role involves providing on-site editorial assistance to the FDA's Center for Biologics Evaluation and Research (CBER), specifically within the Office of Vaccine Research and Review (OVRR). This project is integral to the FDA's commitment to ensuring the availability of safe and effective biologics for the public.
Key Responsibilities:
The Medical Editor will be responsible for:
- Editing and formatting reviews of marketing applications, INDs, and sponsor meetings.
- Collaborating with a team of writers and editors to align with FDA personnel on OVRR's Integrated Review pilot.
- Ensuring high standards of organization and communication throughout the editing process.
- Conducting literature searches to enhance document content.
- Performing quality checks on the work of fellow editors and writers.
- Managing the organization and updates of the SharePoint site.
- Ensuring compliance with Section 508 standards.
- Engaging with FDA stakeholders to define project requirements and deliverables.
- Overseeing project management tasks, including financial forecasting.
- Participating in management activities as directed.
Candidate Profile:
The ideal candidate will possess:
- Experience in editing scientific or user fee documents.
- Strong organizational and time management skills, with the ability to synthesize meeting notes into key discussion points.
- The capability to manage multiple projects effectively under tight deadlines.
- Proficiency in MS Office and EndNote.
- Intermediate knowledge of Microsoft Word, with a willingness to learn advanced features.
Preferred Qualifications:
Additional skills that would be advantageous include:
- Experience with federal government policy documents.
- At least 2 years of copy-editing experience, familiar with style guides such as AP, Chicago, or AMA.
- Knowledge of SharePoint, EndNote, and Visual Basic.
- Understanding of Section 508 compliance.
- Familiarity with the FDA regulatory process.
Education:
A Bachelor's or Master's degree in a STEM discipline is preferred.
At DRT Strategies, we are committed to fostering a culture of professionalism, quality, teamwork, and a focus on customer success. We value diversity and provide equal employment opportunities to all applicants.
Our current work environment allows for remote collaboration, leveraging modern communication tools. Future requirements for onsite work will be communicated in due course.
