Bioanalytical Report Writer
- - Laboratory
- Indianapolis, IN, USA
- Full or Part Time
AIT Bioscience (AITB) is a leading bioanalytical services contract research organization (CRO), serving the pharmaceutical, biotech, and animal health industries. LC-MS/MS and multiple large molecule platforms combine to provide regulatory compliant bioassay support of the development of new medicines from Discovery to Pre-Clinical and Clinical through Commercialization.
AITB is the first and only CRO to provide solutions for all molecule types (large, small, and peptides/biomarkers) in a purpose-built facility utilizing a fully electronic analytical lab notebook system. With our customized, real-time QC system, quality has literally been built into everything we do and everywhere we do it. Bioanalytical capabilities and expertise support both stand-alone projects and full IND/NDA enabling programs, allowing AITB to support its clients with a hands-on approach, scientific collaboration, high quality, and on-time delivery.
To support our continued growth, AITB is seeking a Bioanalytical Report Writer for our Indianapolis location. We ideally seek a full-time candidate working 30-40 hours per week. However, we would also consider part-time candidates working 15-20 hours per week. Work may be performed on-site and/or remotely.
Fully qualified candidates may expect competitive compensation, commensurate with experience. AITB offers a generous benefits package including medical, dental, vision, life, and disability insurance, 401(k) retirement plan, and the opportunity to work with a talented, dedicated and energetic workforce.
Your health and the health of our employees and our families is important. Therefore, we will be utilizing phone and video interviewing in accordance with COVID Stay-at-Home Orders.
Individuals in this position create data tables and reports as requested by project managers. Additionally, they update reports based on Quality Assurance, Project Manager or Client requests. The Report Writer also performs the finalization procedures at the end of a study. Prepares or contributes to the preparation of bioanalytical method validation and bioanalytical sample analysis reports for internal teams on behalf of external clients.
- Takes responsibility for preparing assigned documents to a high standard, working in accordance with established Standard Operating Procedures (SOPs).
- Liaises directly with the internal staff on bioanalytical reporting tasks and ensures on-time completion and delivery.
- Takes responsibility for managing day-to-day workload for assigned tasks and projects, in collaboration with internal staff.
- Keeps abreast of current scientific writing and regulatory knowledge.
- Works within and adheres to company SOPs.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Ability to communicate fluently and effectively in English, both in writing and verbally.
- Proficiency in the use of MS Excel and Adobe Acrobat. Above average proficiency in MS Word, specifically in the use of bookmarks, fields, and templates.
- Familiarity with the structural and content requirements of bioanalytical method validation and sample analysis study reports.
- Knowledge of regulations relevant to bioanalysis, such as Good Laboratory Practices (GLP) and those of other regulatory agencies (e. g., OECD, ICH, MHLW).
- Competence in completing high quality first draft reports within a reasonable time frame and with limited guidance.
- Excellent organizational skills and ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner in order to reconstruct a study using available data from our databases.
- Good understanding of common statistical methods and terms.
- Ability to identify inconsistencies and deficiencies in statistical output as related to acceptance criteria defined in SOPs.
- Careful attention to detail and accuracy.
- Ability to work on several projects at once while balancing multiple and overlapping timelines.
- Demonstrated ability to collaborate with others as well as to work independently.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Associates degree in a life science-related discipline, or in a technical writing, or related field. Bachelor's degree preferred.
- At least 2 years of experience in a medical, clinical, preclinical, chemistry, or related environment; or equivalent combination of education, training, and experience.
Our laboratory runs on a fully electronic platform. Successful candidates will enjoy and be adept at working with technology and computer-based systems. At AIT Bioscience, we value you as a person, support your personal growth and development, and want you to succeed. This opening is a first-shift position, with flexibility needed to occasionally pivot to alternate hours as directed. Qualified candidates please apply and submit your resume and cover letter with desired salary range.