Scientific Report Writer

Req ID #:  225367
Location: 

Shrewsbury, MA, US, 01545

For 75 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

Generate reports for preclinical and clinical studies. Coordinate larger documents with multiple contributing scientists’ reports. Ensure that reports adhere to study protocols, standard templates and styles, Sponsor templates and styles, and applicable regulations.

ESSENTIAL DUTIES AND RESPONSIBILITIES:  
•    Extract information from protocols and study data to generate preclinical and clinical study reports including text tables. 
•    Create data tables for report from automated data collection systems or manual data if applicable.
•    Ensure that tables are an accurate representation of data as indicated by the protocol, clinical phase plan, and amendments.
•    Review contributing scientists’ sub-reports and project scientists’ reports for completeness and adherence to regulatory compliance requirements.
•    Import data tables and contributing scientists’ sub-reports using appropriate technical tools.
•    Create and update electronic report files to maintain document control.
•    Create file-searchable PDF version of the report deliverable and incorporate scientific sub-reports in accordance with FDA guidelines.
•    Prepare documents for submission to the Quality Assurance Unit; assist in resolving audit findings and facilitate the responses of report issues with other departments for QA resolution.
•    Use report progress monitoring database to track scheduling of deliverables to the client.
•    Participate in study-specific pre-initiation meetings as necessary; anticipate reporting issues and suggest courses of action for data collection enhancements or protocol edits.
•    Facilitate meetings with the Study Director or project scientist as necessary for study specific reports and suggest courses of action for data collection enhancements or protocol edits.
•    Assist in the creation of MS Word report templates for the various service types.
•    QC and route study related documents through the signature process.
•    Compile study reports and documentation for shipment to Sponsor.
•    Prepare report and electronic files for submission to archives.
•    Under the direction of the Supervisor, work on process improvement projects to enhance department efficiency, data collection, or data presentation specifically related to the implementation, training and utilization of new systems and software related to reporting.
•    Perform all other duties as assigned.

The pay for this position is between $33.00 and $40/hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Job Qualifications

QUALIFICATIONS:    
•    Education:  Bachelor’s degree (B.A./B.S.) in journalism, computer science, business administration, or related discipline. 
•    Experience:  3 to 5  years related experience in scientific data presentation, writing, editing, proofreading, and publishing. Experience working in a regulated environment required. 

•    An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
•    Certification/Licensure:  Advanced training in applicable software applications required.
•    Other:  Scientific and medical writing knowledge and the ability to apply judgment and discretion 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). Ability to perform file conversion and compilation. Strong written, verbal, and analytical skills. Excellent organizational and communication skills. Ability to work with all levels of staff. Ability to adjust priorities to adhere to stringent deadlines. Knowledge of medical terminology. Familiar with preclinical and clinical study protocols/reports and FDA electronic reporting compliance. Knowledge of GLP regulations.

PHYSICAL DEMANDS:
•    Must regularly operate a computer and occasionally operate other office productivity machinery such as a calculator, copy machine, and computer printer. 
•    Regularly provides information to and receives information from/through various technologies, media, sources and contacts.  Must be able to accurately exchange accurate information in these situations.
•    Must occasionally move about inside the office to access file cabinets, office machinery, etc. 

WORK ENVIRONMENT:
•    General office working conditions, the noise level in the work environment is usually quiet.

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 20,000 employees within 110 facilities in over 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.

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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.

We’re committed to providing benefits that elevate your quality of life.  Based on your position these may include:  bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.

 

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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: Worcester

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