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Clinical Research Medical Writer (NCI)

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Job Number:
648077
Job Category:
Healthcare / Life Sciences / Medical
Location:
FREDERICK, MD US
Schedule:
Full-time
Travel:
Yes, 10% of the time
Shift:
Day Job
Potential for Teleworking:
No
Clearance Level Must Currently Possess:
None
Clearance Level Must Be Able to Obtain:
Public Trust
Description:

PROGRAM DESCRIPTION

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.

KEY ROLES/RESPONSIBILITIES

The Clinical Research Medical Writer is responsible for providing medical writing support to the NIAIDHIV Clinical Research in West Africa project, as well as other CMRP initiatives.  

 

  • Gathers, interprets, and integrates information, maintains proper version control, prepares and summarizes meeting proceedings
  • Attends virtual and in-person meetings that may be located at the NIH campus in Bethesda; Prepares and distributes meeting minutes
  • Coordinates team meetings and assists in the development of meeting agendas
  • Drafts and edits monthly/quarterly/yearly project report deliverables and other documents or reports
  • Prepares monthly in progress review (IPR) performance information in Leidos Biomed Project Management Office (PMO) SharePoint site
  • Writes, revises, and provides editorial assistance for clinical research documents, including but not limited to clinical protocols, Investigator Brochures, clinical study reports, subject consent forms, and publications to medical journals through collaboration with the Principal Investigator (PI)
  • Integrates various sources of information into a uniform style and language for regulatory compliance
  • Ensures submitted documents are clear, complete, and accurate as to required content elements, specific language, and applicable regulatory requirements for human subjects research
  • Drafts and edits Standard Procedures (SPs), Standard Operating Procedures (SOPs), and presentations
  • Collaborates with various groups to assess whether specific project-related documents comply with regulatory requirements and Standard Operating Procedures (SOPs)
  • Composes medical papers from outlines provided by clinicians for presentations
  • Collaborates with high-level managers and various offices across CMRP and company wide
  • Provides expertise in MS Word and Adobe Acrobat to create stable and effective fields, hyperlinks, and references
  • Serves as a subject matter expert in advanced MS Word and Adobe Acrobat functions to ensure proper format, form, and style for documents
  • Creates, maintains, and provides expertise for template documents and related instructions for documents
  • Works collaboratively with other CMRP Medical Writers
  • May travel internationally up to 10%

 


Qualifications:

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

 

  • 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. (Additional qualifying experience may be substituted for the required education) Foreign degrees must be evaluated for U.S. equivalency.
  • In addition to education requirements, a minimum of two (2) years of experience in a pharmaceutical, biotechnology and/or clinical environment which includes 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 Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) guidelines, as well as all practices and procedures related to medical writing
  • Ability to gather and construct assorted project meeting minutes, summaries, reports and documents
  • Proficiency in word processing systems, i.e., Microsoft Word, MS Office or similar systems
  • Ability to work diplomatically with various agencies within complex international environments
  • Must have working knowledge of regulations such as FDA, ICH guidelines and current good clinical practices
  • Experience participating in the preparation of clinical documents for regulatory submissions (e.g., clinical protocols, INDs) 
  • Ability to effectively incorporate diverse feedback into a high quality document
  • Must be able to obtain and maintain a security clearance

 

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

 

  • A Medical Writer Professional with clinical research and/or infectious diseases experience
  • Experience with international research in West Africa
  • Desire to travel internationally

 


Leidos Overview:
Leidos is a global science and technology solutions leader working to solve the world’s toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company’s 33,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported pro forma annual revenues of approximately $10 billion for the fiscal year ended January 1, 2016 after giving effect to the recently completed combination of Leidos with Lockheed Martin's Information Systems & Global Solutions business (IS&GS). For more information, visit www.Leidos.com. The company’s diverse employees support vital missions for government and commercial customers. Qualified women, minorities, individuals with disabilities and protected veterans are encouraged to apply. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an Equal Opportunity Employer.
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