Biodefense Regulated Laboratory Technical Document Writer
Clinical Research Management - Frederick, MD

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Growing and well-respected biomedical (clinical, basic and applied) research firm has openings at USAMRIID. If you are passionate about research, and are looking for a firm that shares your passion, and provides competitive salaries with a strong benefits package, join the ClinicalRM team.

We are currently seeking a Biodefense Regulated Laboratory Technical Document Writer for the Frederick, MD. area.

DESCRIPTION:

This position for a Technical Document Editor is part of USAMRIID’s expansion of its capabilities to perform Medical Countermeasure (MCM) Advanced Test & Evaluation (T&E) to facilitate approval of biomedical products by FDA. The contractor shall have the scientific and regulatory background to work directly with Chief, ORS, Study Directors, principal investigators, nonclinical study teams, project managers, Quality Assurance personnel and GLP Archivist to manage preparation of complex reports and other documents from raw data and/ or processed data. Shall be familiar with FDA guidelines for clinical and non-clinical documents and records, to include GLP requirements. Must have excellent writing skills, close attention to detail, good communication skills and good organizational skills. Must be proficient with Microsoft Office Suite and with use of electronic document management systems. Shall have good skills and abilities to interact with research subject matter experts and other scientific/ support staff in a team environment.

RESPONSIBILITIES:

MINIMUM QUALIFICATIONS:

Qualified candidates will receive consideration for employment without regard to race, color, religion, sex, or national origin. Candidates for positions under ClinicalRM’s contracts with the Department of Defense (DoD) will be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency. Such investigations may include criminal records and credit history checks.

ClinicalRM is an Affirmative Action-Equal Opportunity Employer

www.clinicalrm.com

“NorthCoast 99” Best Places to Work recipient

  • Process and tabulate data and observations into appropriate tables and text following standard templates. Develop and establish templates where needed.
  • Review and edit draft reports and other documents for organization, clarity, use of correct terminology and scientific standards.
  • Prepare documents to include but not limited to nonclinical GLP protocols, SOPs, associated documents, research reports, nonclinical study reports, in compliance with FDA regulations, e.g., 21CFR314, where the goal is inclusion in FDA animal rule submission.
  • Administer receipt, collation, and assembly of documents for review, to include management those processes
  • Manage development and review of large documents with multiple review cycles and short deadlines.
  • Work efficiently on multiple projects simultaneously.
  • Manage documents in an electronic document management databases.
  • Manage organization of retention of study documentation, including electronic raw data, in coordination with Institute GLP Archivist.
  • Participate in study and project meetings to provide input regarding deliverables, timelines, and processes
  • Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer.
  • Performs light duties and other related duties as required and assigned.
  • Position requires a B.S. degree in the biomedical sciences.
  • Must have minimum 6 years’ experience in the pharmaceutical, biotechnology or contract company environment.
  • Preference will be given to those with more technical document preparation and editing experience and expertise.
  • Must be able to work independently following a brief period of specific technical training.

  • Clinical Research Management - 2 years ago - save job
    About this company
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    ClinicalRM is a Contract Research Organization supporting government and commercial clinical research for biologics, drugs, and devices.