Report Writer I, Medical Device Pathology

About the Role

As part of the medical device pathology team at Inotiv, Report Writers play a crucial role in maintaining efficiency and high-quality work. You will help craft clear, concise reports, ensure study data accuracy, push studies to completion, and ultimately contribute to improving human health and patient safety.

Responsibilities

• Prepares pathology report templates and data spreadsheets to provide a formatted, complete, clear, and concise presentation of results, discussion, and conclusion by the Pathologist.
• Performs quality control of study-related data entry spreadsheets and reports to ensure accuracy of results.
• Ensures scheduled studies are monitored and tracked to meet objectives, deliverables, and timelines.
• Supports local and remote Pathologists as needed.
• Requests and organizes applicable data from the Sponsor/Study Director prior to the Pathologist’s evaluation of slides.
• Assists Pathologists in the resolution of audit-related findings.
• Provides clear and accurate documentation of study activities according to Standard Operating Procedures (SOPs) and Good Laboratory Practices (GLP).
• Cross-trains for study work as needed (e.g., necropsy support, histology support).
• Performs administrative study tasks (e.g., setting up study binders and slide receipt/inventory).
• Follows all standard operating procedures (SOPs) and other applicable laboratory or company policies and procedures.
• Maintains confidential information consistent with Inotiv corporate policy.
• Supports and participates in company initiatives as directed.
• Performs periodic review of all applicable SOPs to ensure accuracy and confirm procedures are being performed according to SOPs.
• Participates in SOP writing, reviews, and revisions as needed.
• Completes training requirements as assigned and maintains appropriate training documentation.
• Maintains compliance and adheres to all safety regulations, policies, and procedures, and good documentation practices.
• Interacts with clients, other employees, and the community in a professional manner.
• Performs other duties as assigned.

Requirements

• Bachelor’s degree in a science-related discipline.
• Familiarity with writing and interpreting scientific reports and data.
• Demonstrated proficiency in Microsoft Office Suite (Outlook, Word, Excel) and Adobe Acrobat, with the ability to quickly learn and master new software applications (e.g., Photoshop, InDesign).

Preferred Qualifications

• Prior report writing or Quality Control/Quality Assurance experience.
• One year of experience with data analysis in a research setting.
• One year of experience in a regulated environment (FDA and/or GLP).

Skills

• Good organizational skills and a detail-oriented attitude for quality.
• Strong analytical and problem-solving skills; strong mathematical skills are desirable.
• Understanding of facility SOPs and Good Laboratory Practice Regulations (21CFR, Part 58) as they relate to study-specific services.
• Working knowledge and awareness of general laboratory procedures.
• Proficient in using computers to compile and maintain simple data, spreadsheets, checklists, and reports.
• Good written and oral communication skills.
• Ability to multi-task and prioritize tasks in a high-energy, fast-paced environment.
• Strong time management skills to meet deadlines.

Working Conditions & Physical Requirements

• Light physical activity with prolonged periods of sitting at a desk and working on a computer.
• Requires talking, standing, walking, and repetitive movement of hands and fingers.
• Ability to lift 10–20 pounds occasionally.
• Ability to read and understand applicable materials.
• Use of PPE (Personal Protection Equipment) when required (e.g., latex or nitrile gloves, dust mask or respirator, and safety glasses).
• Manual dexterity to operate laboratory equipment and calculator/computer.

Work is normally performed in a typical interior office environment. Some remote work is possible depending on business needs. The work environment involves exposure to potentially dangerous materials and situations requiring extensive safety precautions, including protective equipment. Exposure to hazardous biological material (e.g., HIV-positive specimens) may require immunization to Hepatitis B or other diseases.

Pay

The salary range for this position is $56,000–$65,000 per year, commensurate with experience and responsibilities. The role may be offered at different levels based on a combination of education and years of experience.

Benefits

• Health and dental coverage.
• Short- and long-term disability.
• Paid time off.
• Paid parental leave.
• 401K and more.