Electronic Submissions - Analyst

Req ID #:  43375
Location: 

Spencerville, OH, 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

 

Responsibilities:

  • Validate software for electronic submissions, which includes requirements gathering, test script writing, test script execution and other validation tasks.
  • Perform review and appraisals of computer hardware, software and associated products for electronic submissions.
  • Ensure work is compliant with applicable guidelines and regulations (e.g., SOP, GLP, PLC, MVP, etc.).
  • Provide software training and support as required to end users and computer department staff.
  • Assist users, with to identifying and resolving software issues.
  • Provide support to users for data capture for electronic submission compliance.
  • Manage standardized glossaries in Centrus and co-ordinate with all other collection system glossaries administrators.
  • Understand industry documents such as the study plan/protocol, study schedules, deviations, drafts and final reports in order to compare them with the electronic data and ensure the data is accurate.
  • Create SEND datasets for electronic submissions and piloting purposes.
  • Assist with global system control change for electronic submissions compliance.
  • Create and maintain user’s templates and implement Provantis Import module for non-Provantis/manual data.
  • Ensure issues are identified, tracked, reported on and resolved in a timely manner.
  • Consistently deliver high-quality services to customers and manage customer expectations effectively.
  • Communicate effectively with customers to identify needs and evaluate alternative business solutions with project management.

 

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

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Nearest Major Market: Lima
Nearest Secondary Market: Findlay

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