SEND Analyst 1 (MWN)

  • Charles River Laboratories
  • Mattawan, MI, USA
  • May 28, 2021

Job Description

For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about. Job Summary We are seeking an experienced SEND Analyst for our Global team located in Mattawan. The SEND Analyst is an integral part of a global team engaged in producing CDISC compliant SEND data sets. Responsible for acquisition of study data from data sources and processing of data through specialized software. Responsible for the preparation of specific domains and/or for the preparation of Define and/or shipment of SEND deliverables to the client. Responsible for developing and executing plans for creation of specific domains and/or Define file creation and/or shipment of SEND deliverables in accordance with User Guides, and industry regulatory guidelines (SENDIG); provide relevant nSDRG (Nonclinical Study Data Reviewer’s Guide) content and/or Define file and/or shipping documentation to ensure accuracy. Correlate SEND domains to ensure alignment with the study report and/or correlate the Define file to SEND dataset content and/or correlate shipping requirements with shipping documentation. The following are minimum requirement related to the SEND Analyst position. Create specific SEND domains and/or Define file in adherence with CDISC standards and/or ship SEND deliverables in adherence with requirements. Understand industry documents such as the study plan/protocol, study schedules, deviations, drafts and final reports; and understand CDISC controlled terminology, if applicable. Ensure work is compliant with applicable guidelines and regulations (e.g., CDISC) Use independent judgement to provide solutions to inconsistencies between SEND data sets and study documentation or to escalate to management in a timely manner. Provide nSDRG content on specific SEND domains, if applicable Consistently deliver high-quality services and regular project status/updates to management. Informs management of any issues that may potentially impact quality and/or on time delivery of SEND data. Maintaining an in-depth understanding of evolving CDISC SEND standards and other regulatory standards/guidance. Education: Bachelor’s degree (B.A./B.S.) or equivalent experience in a scientific or related discipline. Experience: 2 to 3 years related experience in a scientific environment. An equivalent combo of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. About Safety Assessment Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 120 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.