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Report Writer I

Employer
Inotiv
Location
Gaithersburg, MD
Start date
Nov 23, 2021

View more

Discipline
Clinical, Clinical Documentation
Required Education
Bachelors Degree
Position Type
Full time

Job Title:

Report Writer I

Qualifications:

BS/BA degree and/or at least 2 years of experience; excellent computer, communication and writing skills; ability to work independently.

 

Corporate Responsibilities:

  • Adherence to laboratory health and safety
  • Adherence to Standard Operating Procedures (SOPs)
  • Adherence to applicable company policies and guidelines 
  • Adherence to federal and/or local regulations as applicable

Essential Position Responsibilities:

  • Ability to navigate critical reporting software systems (MSWord, Excel, Provantis) and work with scanned document image files.
  • Review study protocols and amendments, prepare reporting schedules, and participate in study meetings.
  • Monitor critical phases of study and interact with toxicology staff and subcontractors, as needed, for compliance with protocol, SOPs and applicable regulations.  
  • Perform periodic reviews of study data and prepare data summaries for Study Directors and clients as required.
  • Compile data tables and materials/methods for multiple toxicology reports and data packages, concurrently.  
  • Verify findings and review raw data, consulting the Study Director regarding any abnormalities.
  • Address applicable findings from QA audits and coordinate receipt of responses from operational groups.
  • Work with Study Director to incorporate client comments into a revised draft.
  • Oversee disposition of study specimens, i.e., test article, formulations, blood samples, preserved tissue.
  • Finalize study report and coordinate archiving activities.

Additional Position Responsibilities: (if applicable)

  • Assist other Report Writers and Study Directors as needed.
  • Communicate with clients as needed.
  • Perform other duties as assigned.

Additional Requirements:

·         Overtime and weekend work as required.

·         Work may require the use of PPE (personal protective equipment)

Professional Responsibilities:(if applicable)

·         Attend continuing education courses, as appropriate.


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