Report Administrator 1 1

Req ID #:  136753
Location: 

Ashland, OH, US, 44805

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 a Report Administrator 1 for our Safety Assessment group site located in Ashland, Ohio.

 

Responsible for finalization of interim and full study reports for assigned studies in accordance with Good Laboratory Practice Regulations and Standard Operating Procedures with a moderate level of supervision/instruction.  

 

Responsibilities:

  • Assist Study Director and department management in monitoring finalization process of assigned studies.
  • Collation and quality control of data and report pieces.
  • Ensure that all protocol and amendment requirements are met with respect to final report data.
  • Ensure final reports meet regulatory and client requirements.
  • Generation and publication of electronic reports using appropriate publishing software.
  • Collaboration with Study Director, departmental personnel, the Quality Assurance department, and client (as necessary) for review and incorporation of client comments.
  • Collaboration with other appropriate company personnel as needed. 
  • Keep current with changing technology.
  • Other duties as assigned by departmental management.

 

Qualifications:

  • AS degree in a natural sciences/technical writing/computer sciences field.
  • 1-2 years related experience in scientific data presentation, writing, editing, proofreading, and publishing. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
  • This position requires strong organizational skills and attention to detail required. Must be familiar with medical terminology and have a thorough understanding of technical aspects of research studies. Scientific and medical writing knowledge and the ability to apply judgment and discretion in order to extract appropriate data and evaluate how to present it. Proficient skills with spreadsheet, word processing, database, and publishing software (e.g. MS Excel®, Word®, and Adobe® Acrobat® PDF software).
  • Strong written, verbal, and analytical skills. Ability to work with all levels of staff. Ability to adjust priorities in order to adhere to stringent deadlines. Familiar with preclinical study protocols/reports and FDA electronic reporting compliance. Knowledge of GLP regulations.

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 300 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 17,000 employees within 90 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 2019, revenue increased to $2.62 billion.

 

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 2019.

 

Equal Employment Opportunity

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

 

If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

 

For more information, please visit www.criver.com.


Nearest Major Market: Cleveland
Nearest Secondary Market: Mansfield

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