Share this Job

IT Analyst - Electronic Submissions

Req ID #:  44871
Location: 

Mattawan, MI, US

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

Prepares, publishes, QCs and delivers paper and electronic components of all submissions including initial large marketing authorization applications and regulatory submissions. Submissions are produced with electronic publishing tools in compliance with document management standards. Performs activities related to enterprise-wide regulatory management systems, including systems coordination, training others, developing and implementing plans, and providing input to systems designs. Ensures continuous efficiency and effective process improvement measurements are conducted to evaluate external vendors.

We are seeking SEND analysts for our Safety Assessment site located at Mattawan. 

The following are responsibilities related to the SEND analyst postion:

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. Perform quality control review with great attention to detail on the resulting SEND domains 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.

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.

 

About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

 

With over 14,000 employees within 80 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2018, revenue increased by 22% to $2.27 billion from $1.86 billion in 2017.

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of ~85% of the drugs approved by the FDA in 2018.

 

Equal Employment Opportunity 

 

Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet

.


Nearest Major Market: Kalamazoo

Job Segment: Toxicology, Biotech, Electronics, Pharmaceutical, Laboratory, Science, Technology