Medical Writer I

DEPARTMENT: Medical Writers

REPORTS TO: Department Manager

SUMMARY

Independently facilitate and oversee the coordination, assembly, writing, editing, and quality control of study/data reports and/or protocols that accurately reflect the study data and fulfill all protocol and GLP requirements. Additionally, the Medical Writer will be involved in the development of report and data structure and presentation formats with preparation of text tables and/or associated graphs for reports and/or presentations.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
  • Coordinate with and assist Study Director in the presentation of data and writing of report
  • Organize the overall layout of study from constituent parts (sub-reports, etc.)
  • Assure the completeness of collection, assembly and organization of raw data
  • Ability to work within established timelines
  • Write materials and methods section of study reports, evaluating the study data to assess whether the methods documentation meets the requirements of the study protocol.
  • Manage the organization of report sections including formats, presentation of data (i.e., tables, graphs, etc)
  • Prepare file-searchable PDF version of the report deliverable (i.e., bookmarks).
  • Prepare report and electronic files for submission to the DSU.
  • Participate in study-specific pre-initiation meetings; anticipate reporting issues and suggest courses of action for data collection enhancements or protocol edits.
  • Proofread/copyedit study protocols prior to submission for Study Director signature.
  • Ability to perform quality control on draft editions of reports, other documents/data and sub reports (i.e., assisting in the generation of the Veterinarian sub-reports).
  • Coordinate and communicate with participating departments, sponsors and outside vendors to help ensure timely delivery, organization and generation of the report
  • Assist in the production and/or write scientific publications
  • Assist in development of formats, templates, and general guidelines for documentation.
  • Participate in departmental or interdivisional process improvement and training initiatives.
  • Perform all other related duties as necessary/assigned
QUALIFICATIONS:
  • Education: Bachelor’s or Master’s degree in biological sciences, technical writing or equivalent field (with significant course work in biological sciences).
    • Exceptional experience in a related field could substitute for the education requirement.
  • Experience: Minimum four years experience in a regulatory pre-clinical or clinical testing environment with involvement in medical writer related activities.
    • Exceptional experience in related preclinical/clinical areas could substitute (e.g., study coordination or data coordination).
  • Certification/Licensure: Driver’s license
  • Other:
    • Knowledge of domestic and foreign GLP regulations as they relate to reporting requirements and to study conduct.
    • Proficiency with Windows-based word processing, spreadsheets and presentation software.
    • Ability to multi-task with good communication, interpersonal, and organizational skills.
    • Ability to adjust priorities in order to adhere to stringent deadlines.
    • Ability to perform under pressure in a fast-paced, multi-task, deadline oriented environment.
    • Advanced working knowledge of Microsoft Word, Excel, and Adobe Reader.
    • Must be skilled in using and developing document templates.
PHYSICAL DEMANDS: N/A
WORK ENVIRONMENT:
  • General office working conditions, with generally quiet noise conditions.
  • Exposure to laboratory areas with mild noise/odors.
WORK ENVIRONMENT:
  • This position may require occasional domestic travel or performing duties on weekends and/or
    holidays.

All employees are required to satisfactorily perform the essential duties and responsibilities of their position. • The essential duties and responsibilities listed above are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required. • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.

If you are interested in this opportunity please send your CV to jobs@cbset.org.