Technical Writer I (Clinical Research)

Frederick National Laboratory
Frederick, MD
Feb 10, 2021
Feb 25, 2021
Full Time
Technical Writer I (Clinical Research) Job ID: req1682 Employee Type: exempt full-time Facility: Frederick: INDUS Location: 5705 Industry Lane, Frederick, MD 21704 USA The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases. Our core values of accountability, compassion, collaboration, dedication, integrity, and versatility serve as a guidepost for how we do our work every day in serving the public's interest. Position Overview: PROGRAM DESCRIPTION Within Leidos Biomedical Research Inc., operator of the Frederick National Laboratory for Cancer Research, the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to high-profile domestic and international clinical research initiatives sponsored by the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH), and several other institutes within NIH. CMRPD's ability to provide rapid responses and high-quality solutions, and to recruit and retain experts with a variety of backgrounds, allows the directorate to facilitate strategic support to the growing clinical research portfolios of NCI, NIAID, and other NIH divisions/offices/centers. CMRPD's support services are aligned with the program's mission to provide comprehensive clinical trials operations and program/project management services to advance scientific clinical research that complies with applicable regulations and guidelines, maintains data integrity, and protects human subjects. CMRPD services include clinical trials monitoring, regulatory affairs support, clinical safety oversight, protocol navigation/protocol development, and programmatic and project management support to facilitate the conduct of more than 400 Phase I, II, and III domestic and international trials annually. These trials investigate the prevention, diagnosis and treatment of cancer, influenza, HIV, infectious diseases and emerging health challenges like Ebola virus and COVID-19, heart, lung, and blood disorders, parasitic infections, and rare and neglected diseases. CMRPD's collaborative approach to clinical research support and the expertise and dedication of staff to the continuation and success of CMRPD's mission has contributed to improving the overall standards of public health on a global scale. KEY ROLES/RESPONSIBILITIES Provides editorial and writing support for overarching CMRPD projects/initiatives Writes/edits comprehensive annual reports on CMRPD activities, ensuring compliance with contract requirements and as directed by CMRPD management Develops, reviews, and edits documents, including but not limited to, clinical research protocols, informed consents, clinical study reports, research support proposals, meeting summaries, standard procedure documents, internal newsletters, scientific manuscripts, posters, PowerPoint presentations, and other clinical research publications Ensures documents are clear, complete, and accurate as to required content elements, specific language, and applicable regulatory requirements for human subjects' research Serves as a subject matter expert in advanced Microsoft Word functions to ensure proper format and style for documents Creates, maintains, and provides expertise for template documents and related instructions for documents Collaborates with technical project managers, other CMRPD writers, and various offices across the directorate to support writing and editing assignments Performs literature reviews, gathers information, collates, and summarizes material to prepare clearly written reports, guidelines, and project summaries Maintains proper version control Summarizes meeting proceedings in support of various clinical research initiatives This position is located in Frederick, Maryland BASIC QUALIFICATIONS Possession of Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for US equivalency No work experience required with a Bachelor's degree Strong written communication skills, with meticulous attention to detail and expertise in grammar and standard styles Professional writing and proofreading skills to support preparation of clear and concise documents Familiarity with medical and scientific terminology, regulatory environments, and clinical research practices Proficiency using Microsoft Word, PowerPoint, and Adobe Acrobat with the ability to troubleshoot and solve formatting issues Ability to effectively incorporate diverse feedback into well-written summaries, reports, protocols, and other document types Ability to manage timelines, ensure adherence to deadlines, perform detail-oriented tasks, and prioritize multiple complex projects concurrently Ability to function independently and/or collaboratively within a team setting to produce high-quality material compliant with established guidelines, practices and procedures related to medical writing Ability to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Candidates with these desired skills will be given preferential consideration: Two (2) years experience with demonstrated professional medical/technical writing skills, preferably in a health-related field, clinical environment, or biomedical industry Familiarity with FDA and ICH/GCP guidelines Experience in the clinical research field Knowledge of regulatory environment Experience using Microsoft Visio Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW) #readytowork

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