Technical Scientific Writer

Technical Scientific Writer Req ID #:  65134 Location: 

Shrewsbury, MA, US, 01545 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 Technical Writerfor our Biologics Testing Solutionssite located in Shrewsbury, MA.

The following are responsibilities related to theTechnical Writer:

• Collaborate with CRL scientists, study directors, technical and production staff to devise, draft, edit and finalize reports, protocols, SOPs, Client Test Methods and other client or regulatory documents in a format approved by regulatory agencies and CRL Quality Assurance (QA). Continuously review, or assist in the review of, documents describing laboratory procedures and techniques to ensure documents reflect laboratory procedures and techniques as currently practiced. Revise documents as necessary.

• Revise existing document templates to improve data recording procedures and efficiency, and/or to improve overall means of meeting client expectations and achieving regulatory compliance in activities performed at CRL.

• Work with document control to process documents. May enter protocols, Client Test Methods SOPs, forms and other regulatory documents into a database, and assist QA in finalizing such documents.

• Participate in training activities on methods of regulatory documentation and compliance.

• Assist in developing documentation for potential sponsors of new studies.

• Develop information formats and shared documents.

• Perform all other related duties as assigned.

The following are minimum qualifications related to theTechnical Writerposition:

• Education: Bachelor’s degree (B.A./B.S.) or equivalent in biology or related discipline.

• Experience: 2 years related experience in a laboratory setting.

• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

o Knowledge of cGMPs or regulatory affairs pertaining to the pharmaceutical and biological industries is preferred. Strong organizational and prioritization skills required.

o Ability to understand and use internal software programs such as LIMS required.

About Biologics Testing Solutions

With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs.  Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.

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 2018, 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

Nearest Major Market: Worcester

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