Medical Writer III

Within Leidos Biomedical Research Inc., the Clinical Monitoring Research Program Directorate (CMRPD) 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 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, CMRPD'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. CMRPD's support services are strategically aligned with the program's mission to provide comprehensive, dedicated support to assist National Institutes of Health (NIH) 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, CMRPD services include comprehensive clinical trials monitoring, 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. CMRPD'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.

The Clinical Monitoring Research Program Directorate (CMRPD) provides comprehensive clinical and administrative support to the National Cancer Institute's (NCI's), Center for Cancer Research (CCR), Office of Regulatory Affairs (ORA) providing medical writing and protocol. Navigation support.

KEY ROLES/RESPONSIBILITIES

Medical Writer III

• Assist Principal Investigators with scientific protocol writing and editing (including format and addition of administrative sections), prepare amendments and all necessary forms, and development of final reports/manuscripts
• Assist staff with improving the quality of written communications
• Assist with the development of clinical trial protocols, informed consent documents, IND documents and Investigator Brochures
• Develop protocols and clinical documents summarizing scientific discussions related to protocol development projects
• Compose medical papers from outlines provided by clinicians/scientists for presentations
• Assist with development of recruitment materials, newsletter announcements, web information, and other public relations-related documents, if requested
• Develop manuscripts summarizing scientific discussions related to program-related projects
• Edit, rewrite, or otherwise prepare publication manuscripts on clinical studies and scientific reports including special summaries from raw data for submission to the FDA or for in-house use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication
• Ensure protocol and informed consents meet regulatory requirements and are written in a compatible format with the guidelines
• Prepare draft documents for senior staff review
• Perform background research; compile and review references to compose background clinical trial information; and review various documents to draft the pharmacological and risks sections of the research documents
• Attend in-person meetings located at the NIH campus in Bethesda
• Collaborate with NIH medical research scientists, Principal Investigators, Protocol Navigators, and safety, regulatory, and monitoring divisions
• Coordinate with other offices (policy, web, communication, etc.) to integrate and ensure consistency of new/revised documents with policies
• Serve as a lead contact to the protocol development team sharing information and establishing working relationships
• Track status of documents in the system for compliance with specified timelines
• This position is located in Frederick, Maryland

BASIC QUALIFICATIONS

• Possession of a Bachelor's degree from an accredited college/university in biological/biomedical science (Additional qualifying experience may be substituted for the required education)
• Foreign degrees must be evaluated for U.S. equivalency
• A minimum of five (5) years of experience in a pharmaceutical, biotechnology and/or clinical environment including a minimum of two (2) years medical and regulatory technical writing/editing
• Ability to communicate effectively both verbally and in writing with demonstrated expertise with grammar, syntax, and format
• Demonstrated 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
• Proficiency in word processing systems (e.g., Microsoft Word, MS Office or similar systems)
• Must be familiar with department specific documentation systems and up-to-date on regulations such as FDA, ICH guidelines and current good clinical practices
• Must have experience and significant participation in preparation of clinical documents for regulatory submissions (e.g., clinical protocols or INDs)
• Ability to incorporate diverse feedback into a high quality document
• Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

• Proficiency in EndNote

Expected Competencies:

• Proficiency in word processing systems, including MS Word, Adobe Acrobat
• Demonstrated expertise with grammar

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)