Reynolds American Inc. (RAI) Clinical Project Manager in Winston Salem, North Carolina
Clinical Project Manager
Date: Aug 2, 2020
Location: Winston Salem, NC, US
Company: British American Tobacco
Job Number: 26228
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 Reynolds American, 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.
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.. This position is with RAI Services Company (2200) .
Here, you’ll have the opportunity to work on iconic brands and revolutionary products by collaborating with visionary, principled and passionate people every day.
Through interpretation, guidance, direction, and oversight of FDA regulatory compliance, Scientific & Regulatory Affairs (S&RA) provides strategic and tactical leadership to the business while growing our people and sustaining product marketability. S&RA strives to be respected leaders in regulatory science, engagement, compliance, and quality to transform tobacco and support our products.
RAI Services Company (RAIS) is seeking a qualified Clinical Project Leader (Senior Scientist) to support the oversight, outsourcing and project management of clinical studies with new and existing tobacco products consistent with RAIS’ Growth, Innovation, and Harm Reduction Platforms.
The incumbent will actively collaborate with the Clinical Studies team, other members of Scientific & Regulatory Affairs, Product Development teams, and senior management regarding the design, oversight and execution of clinical studies and submission of the resulting data.
The individual must be able to independently lead, manage and/or execute multiple projects simultaneously. The Clinical Project Leader will actively partner across functional areas within RAIS and RJ Reynolds Tobacco Company R&D and with external vendors to ensure project deliverables and timelines are met.
Principal Duties and Responsibilities:
Direct, supervise, and/or coordinate a program of studies or the day-to-day execution of clinical studies outsourced to contract research organizations.
Lead and/or work collaboratively with project study teams comprised of internal staff and external vendors.
Develop and maintain relationships for oversight of contracted vendors
Review, interpret, and/or apply research concepts from regulatory agencies to RAIS clinical studies.
Ensure that studies are designed and conducted in compliance with Good Clinical Practices (GCP) requirements, applicable FDA regulations/guidance, and RAIS Standard Operating Procedures.
Contribute to, or assist with the study design and interpretation of resulting data to support product development, regulatory submissions, and exploratory research.
Required Knowledge and Experience:
PhD, Master’s, or Bachelor’s degree required in biology, chemistry, toxicology, pharmacy, public health, clinical research, or related discipline; or equivalent experience.
Three to five years of work experience in clinical research, preferably with experience in leading clinical studies.
Demonstrated high level project management skills, especially timeline and team management.
Experience with FDA regulatory submissions.
CCRC, CCRA, CCRP or Project Management certification.
The Ideal Candidate will possess:
Ability to drive collaborative efforts cross-functionally and externally with outsourced vendors.
Excellent relationship management
Strong project management skills
Critical Thinking skills
Ability to work and make decisions with minimal supervision.
Excellent time management and team collaboration skills.
Excellent oral and written communication skills.
Proficiency in MS Word and Excel
Client-focused approach to projects
Ability to creatively contribute to key strategies at the department/division/enterprise level.
- Regular attendance at work.
Competitive Annual Salary
Targeted Annual Bonus
Relocation assistance available for those who qualify.
Our company offers very competitive 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
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.
Only applicants requiring reasonable accommodation for any part of the application and hiring process should contact us directly via email at TalentAcquisition@RJRT.com.
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Nearest Major Market: Salem
Nearest Secondary Market: Winston
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