Regulatory Communications Coordinator

Regulatory Communications Coordinator Req ID #:  178631 Location: 

Wilmington, MA, US, 01887 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 Responsible for supporting the corporate regulatory communication program which runs on various media such as i-Connect, Teams, and other technology software and database platforms.  The Regulatory Communication Coordinator will work closely with GQSC management by directly supporting the administration and delivery of programs for research of contemporary regulatory intelligence, internal regulatory training materials, webinars/symposiums, and publication of regulatory newsletters intended for internal colleagues and external publications (e.g., Eureka, LinkedIn, YouTube).

ESSENTIAL DUTIES AND RESPONSIBILITIES:   Ownership of the iconnect/Sharepoint site by ensuring content/information, updates are maintained. Ensure that various platforms provide overall direction, administration, and management of the company’s Regulatory Affairs program.  Deliver products/content utilizing contemporary web design and metric reporting tools (e.g., Adobe Creative Suite, Photoshop, InDesign, Audition, Premiere, Power BI.  Working with regulatory SME team members, ensure that the final product can be launched according to presenter’s timeline and formatting requests. Promote or host training and webinar events. Work across internal communication, marketing, IT, and iConnect stakeholders to ensure consistency in product quality, format, and delivery. Establish strong communication relationships with key corporate stakeholders (e.g., Corporate Communications, Marketing, IT). Work with stakeholders by ensuring that the regulatory inspection database is updated. Work directly with application teams (system administrator and developer) on audit and inspection metrics collection and reporting to ensure they are aware of any requested updates.  Provide support for creative aspects of internal and external communications, including newsletters, press releases, staff announcements, posters, and other publications.  Develop short- and long-range goals, for enhancing/expanding regulatory communications program, including organizational structure, staffing requirements, and tools/applications. Role may require the assumption of additional duties as assigned or as needed to support departmental or organizational goals. Job Qualifications Education:  Bachelor’s degree (B.A. /B.S.) or equivalent in a scientific or related discipline. Experience:  Three to Five years related experience in a technology role/skill set. Communications or journalism experience is helpful. Working knowledge of the Pharma/Biotech industry, as well as an understanding of GxP regulations. Skill set: Strong interpersonal and writing/communication skills (oral, written, visual); creative software experience, research skills with the ability to distill complex topics into easily consumable message or print. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. Certification/Licensure:  Technology certifications preferred. Other: Knowledge of US 21 CFR parts 58, 210/211, and 820 and OUS related guidance documents. 

  Competencies Lead - We lead when we advocate our purpose and model our values, when we deliver innovation, when we embrace change, and when we appreciate and celebrate the great work of others.Care - We show we care when we respect each other, our animals and the communities where we work and live, when we create a positive healthy workplace, when we are mindful of our compliance standards, and when we choose to do the right thing.Collaborate -We collaborate when we partner with each other and promote teamwork, when we communicate clearly and effectively across the hall or around the globe, and when we welcome all forms of diversity and encourage inclusiveness.Own - We act like owners when we hold ourselves accountable for our actions, when we respond to internal and external client needs with speed and accuracy, when we set and achieve meaningful goals, and when we strive towards continuous improvement.

Vaccine Mandate

Charles River is a U.S. Federal Contractor.  As a result, we must follow the Presidential Executive Order to mandate vaccinations, and ensure our employees are fully vaccinated against COVID-19.  Our main priority is the wellbeing, health, and safety of our people. We require proof of vaccination from all employees. 

Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition (crrecruitment_US@crl.com) so that information can be provided about the accommodation process at Charles River.

About Corporate Functions

The Corporate Functions provide operational support across Charles River in areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development. They partner with their colleagues across the company to develop and drive strategies and to set global standards. The functions are essential to providing a bridge between strategic vision and operational readiness, to ensure ongoing functional innovation and capability improvement.  

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 18,000 employees within 100 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 supported the development of >80% of the drugs approved by the FDA for the past 3 years.

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.

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: Boston

Job Segment: Pharmaceutical, Laboratory, Testing, Recruiting, Science, Research, Technology, Human Resources