Leidos Biomedical Research, Inc. (LBRI), a wholly owned subsidiary of Leidos, operates the Frederick National Laboratory for Cancer Research (FNLCR). FNLCR is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI). It is the only FFRDC dedicated to biomedical research. Through its status as an FFRDC, FNLCR provides NCI and others with a unique national resource to accelerate the development and delivery of effective preventive, diagnostic, and therapeutic products for cancer and AIDS.
The breadth of FNLCR’s activities spans the research and development spectrum, including investigator-initiated, hypothesis-driven research into cancer and AIDS; advanced technology programs focused on genetics and genomics, proteins and proteomics, imaging, nanotechnology, bioinformatics, and laboratory animal sciences; clinical operations in support of NCI and National Institute of Allergy and Infectious Diseases (NIAID)-sponsored clinical trials, as well as NCI drug discovery and development efforts; and management and operations of biopharmaceutical development and manufacturing programs under current Good Manufacturing Practice conditions for NCI and NIAID. Administrative, procurement, financial, safety, and facilities support is provided to these R&D activities through state-of-the-art business processes. LBRI has approximately 1,900 employees and manages an annual operating budget of approximately $450M.
For more information about Leidos Biomedical Research Inc., please visit our webpage at https://www.leidos.com/about/companies/leidos-biomedical-research.
Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Institute of Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale.
This is a part-time position with benefits, approximately 30 hrs/week
The Clinical Monitoring Research Program/Regulatory Compliance and Human Subjects Protection Program (RCHSPP) provides clinical trial management support to the National Institute of Allergy and Infectious Diseases (NIAID) Intramural Clinical Research Community, Division of Clinical Research (DCR), Office of Clinical Research Policy and Regulatory Oversight (OCRPRO).
As part of the Protocol Navigation/Protocol Development Program (PN/PDP), the Medical Writer II: 1) writes, revises, and provides editorial assistance for clinical research protocols from concept to Institutional Review Board (IRB) submission, 2) writes compatible informed consent documents, 3) ensures protocol and informed consents meet regulatory requirements and are written in a format consistent with the guidelines set forth by NIAID; 4) works closely with the IRB to keep abreast of new guidance related to protocol and informed consent submissions for both initial reviews and amendments, and shares relevant information with PN/PDP team members, 5) collaborates with medical research scientists/Principal Investigators (PIs), Protocol Navigators (PNs), and safety, regulatory, and monitoring divisions to ensure writing deliverables are at the highest level of preparation, 6) integrates various sources of information into uniform language styles and analyzes documents for accuracy, consistency, relevancy, correctness of conclusions, alternate hypotheses, editorial corrections, and other issues for regulatory compliance, 7) collates multiple reviewers’ comments, analyzes applicability, and edits documents to reviewers’ satisfaction, 8) coordinates with PIs and PNs to ensure stipulations from approving bodies (e.g., scientific review, IRB, and radiation safety) are addressed appropriately and in a timely manner, 9) provides drafting and editing support as needed for other related research documents, protocol amendments, and continuing reviews, 10) performs literature reviews and background research, 11) prepares and summarizes meeting proceedings, 12) compiles scientific references and creates bibliographies using EndNote software, 13) may draft and edit Standard Operating Procedures (SOPs), meeting minutes, abstracts, manuscripts, and presentations to support the NIAID intramural research or program initiatives, 14) independently works under the general guidance of the supervisor, and 15) attends in-person meetings located at the National Institutes of Health campus in Bethesda, Maryland
Possession of a Bachelor’s degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in biological/biomedical science or related field or 4 years related experience in lieu of degree
Foreign degrees must be evaluated for U.S. equivalency
A minimum of two (2) years’ experience in a pharmaceutical, biotechnology and/or clinical environment which includes medical and/or regulatory technical writing/editing
Current working knowledge of the Department of Health and Human Services (DHHS) regulations, International Conference on Harmonization/Good Clinical Practices (ICH/GCP), Food and Drug Administration (FDA), and Office of Human Research Protections guidelines
Experience participating in the preparation of clinical documents for regulatory submissions (e.g., clinical protocols, Investigational New Drugs [INDs])
Ability to effectively communicate both verbally and in writing with demonstrated expertise with grammar, syntax, and format
Ability to write and edit clear, concise clinical documents compliant with FDA and ICH guidelines, as well as all practices and procedures related to medical writing
Ability to write concise meeting summaries and/or meeting minutes and create action plans
Ability to prioritize workload and submit high quality deliverables in a professional environment under tight deadlines
Ability to work in a clinical research regulatory setting, both independently and within a team, to coordinate, negotiate and facilitate the program goals
Strong collaborative skills with ability to build relationships within multiple groups
Must be detail-oriented and possess substantial organizational skills
Proficiency in word processing systems, i.e., Microsoft Word, MS Office, or similar systems
Familiarity with therapeutic area of allergy and infectious diseases