Reynolds American Inc. (RAI) Scientist - Regulatory Specialist in Winston Salem, North Carolina
Scientist - Regulatory Specialist
Date:Jan 1, 2020
Location:Winston Salem, NC, US
Reynolds American Incorporated is positively transforming the tobacco industry. We’re a family of companies that strives for success in everything we do. The future inspires us because our people are igniting the breakthroughs that are redefining the ways adult tobacco consumers enjoy tobacco in the 21st century.
When other companies talk about growth, they only talk about size. At RAI, we focus on the growth of our people. We take pride in each other’s growth and well-being throughout our careers. We invest in your career and total well-being because we know our companies succeed when our people thrive.
At the RAI companies you’ll have the opportunity to work on iconic brands and revolutionary products by collaborating with visionary, principled and passionate people every day.
This position is within Reynolds American Services Company—a subsidiary that provides support services, including compliance, HR, law, finance, information management, and more to all of the subsidiaries of RAI.
Reynolds American Inc. (RAI) and its operating companies are leading the way in transforming the tobacco industry. To that end, research related to tobacco harm reduction is central to efforts within the Scientific & Regulatory Affairs (S&RA) function at RAI Services Co. (RAIS), and across the RAI enterprise. RAI is committed to working with regulatory agencies to ensure that adult smokers have access to tobacco and nicotine products that have the demonstrated potential to reduce the many health risks attributable to smoking.
S&RA is currently seeking a qualifiedScientist – Regulatory Specialistto maintain trial master files to ensure completeness, quality, accuracy and compliance with SOPs, policies, and regulatory requirements. The successful candidate will join our clinical studies team within Scientific and Regulatory Affairs. The successful candidate will be expected to work collaboratively with various internal and external groups/clients to provide broad regulatory support and to manage multiple projects to ensure timelines are met.
Principal Duties & Responsibilities:
Responsible for working with study teams to manage trial master file (TMF) records, both electronically and paper based.
Performs quality reviews of TMF content.
Ensures upload of documents and study specific TMFs are inspection ready.
Performs quality control checks on documents generated by internal and external partners.
Provides guidance to internal personnel and external partners to answer questions, and address issues and requests regarding TMF process.
Participates in collaborative study teams comprised of internal staff and external vendors to ensure project deliverables are met.
- Associate or bachelor’s degree required.
Experience in document management, records management and archival procedures.
Strong computer skills.
Excellent attention to detail.
Ability to handle multiple priorities and projects.
Excellent team collaboration skills.
Experience working in a regulated environment.
Experience with FDA regulatory submissions.
Experience in tobacco research.
Detailed knowledge of regulatory/clinical documents.
Understands Good Clinical Practice, ICH guidelines and relevant regulatory requirements.
Experience working in an electronic TMF system.
Competitive Annual Salary
Targeted Annual Bonus
Relocation assistance available for those who qualify.
Our company offers very competitive compensation and benefit plans, including:
401(k) plan that offers opportunity to save on pre- and post-tax basis up to 50 percent of eligible compensation. Company matches 100 percent of employee pre-tax/Roth (401k) contributions up to six percent
Comprehensive health- and welfare-benefits package
Eleven paid company holidays annually, plus a generous paid vacation plan based on length of service
Company-paid sick and personal days, funeral leave and jury duty leave
Confidential personal financial counseling service
On-site health clinics and fitness centers
A matching grants program that enables employees to direct and double their donations to qualifying charitable organizations of their choice
Health-care advocacy service
Volunteer service opportunities
Federal credit union membership through Allegacy Federal Credit Union
Extensive training opportunities
ABOUT OUR ORGANIZATION:
Reynolds American Inc. is an indirect, wholly owned subsidiary of British American Tobacco p.l.c., and the U.S. parent company of R. J. Reynolds Tobacco Company; Santa Fe Natural Tobacco Company, Inc.; American Snuff Company, LLC; Niconovum USA, Inc.; Niconovum AB; R. J. Reynolds Vapor Company; Lorillard Licensing Company, LLC; and Reynolds Brands, Inc..
Reynolds American Inc. and its affiliated companies is an Equal Opportunity / Affirmative Action Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Our organization offers a level of challenge, responsibility and creativity for motivated employees that stands apart from the crowd.
We are also committed to employing a diverse workforce and valuing different perspectives, experiences and talents to maximize the company's potential for successfully achieving its business objectives.
Onlyapplicants requiring reasonable accommodation for any part of the application and hiring process should contact us directly.
Nearest Major Market:Winston-Salem
Apply now »