Report Writer I, Medical Device Pathology

About this role

At Inotiv, we’re committed to our purpose of helping our clients discover and develop life-changing therapies for people around the world. As part of the medical device pathology team, our Report Writers are crucial to keeping our work efficient and high-quality. We help craft clear, concise reports, make sure our study data is accurate, help push studies to completion, and ultimately improve human health and keep patients safe.

To perform this job successfully, an individual must have the knowledge, skills, and abilities identified below and perform each essential duty and responsibility satisfactorily, either with or without reasonable accommodation. The below is intended to describe the general content of and requirements for this job’s performance and is not to be construed as an exhaustive statement of essential functions, responsibilities, or requirements.

Key Accountabilities • 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 the 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) SOP/GLP requirements. • Cross-trains for study work as needed (i.e., necropsy support, histology support). • Performs administrative study tasks (i.e. setting up study binders and slide receipt/inventory).

Other • 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.

Critical Success Factors • Good organizational skills. • An attitude for quality; detail oriented. • Strong analytical and problem-solving skills; strong mathematical skills is desirable. • Demonstrates an understanding of facility SOPs and Good Laboratory Practice Regulations (21CFR, Part 58) as they relate to study specific services provided, this job description and general facility operations. • A working knowledge and awareness of general laboratory procedures. • Proficient in the use of a computer to compile and maintain simple data, spreadsheets, checklists and reports for records and inventory, utilizing the appropriate software. • Good written and oral communication skills. • Ability to multi-task and prioritize tasks in a high energy, fast paced environment. • Manages time to appropriately meet deadlines.

Minimum Requirements • Bachelor’s degree in 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 ability to quickly learn and master new software applications as needed (Photoshop, InDesign, etc.)

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

Working Conditions & Physical Requirements The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

(The phrases “occasionally,” “regularly,” and “frequently” correspond to the following definitions: “occasionally” means up to one-third of working time, “regularly” means between one-third and two-thirds of working time, and “frequently” means two-thirds and more of working time.)

General • Ability to read, write, speak and understand English

Physical Activity • Light physical activity. • Prolonged periods of sitting at a desk and working on a computer. • Requires talking, standing, walking and repetitive movement of hands, fingers, reaching and lifting 10 -20 pounds. • Ability to read and understand applicable materials. • Use of PPE (Personal Protection Equipment) when required (i.e., able to wear latex or nitrile gloves, dust mask or respirator, and safety glasses as required). • Manual dexterity to operate laboratory equipment and calculator/computer.

Working Conditions • Work is normally performed in a typical interior office environment. Many job functions require being on-site, but some remote work is possible, depending on business needs. • Work environment involves exposure to potentially dangerous materials and situations that require following extensive safety precautions and may include use of protective equipment. • The noise level is usually moderate. • This position may be involved with radiant/electrical energy, solvents, grease, oil, irritants, acids, bases, and other hazardous chemicals, electro-mechanical hazards, flammable materials and biohazards. Due to exposure to hazardous biological material (which may include HIV positive specimens), immunizati

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