Electronic Submission Publisher

Reynolds American is evolving at pace into a global multi-category business. Our purpose is to create A Better Tomorrow™ by Building a Smokeless World. 

To achieve our ambition, we are looking for colleagues who are ready to join us on this journey! Tomorrow can’t wait, let’s shape it together! 

WE ARE LOOKING FOR ANELECTRONIC SUBMISSION PUBLISHER

SENIORITY LEVEL: Junior Level

FUNCTION: Scientific & Regulatory Affairs 

LOCATION: Winston Salem, NC

ROLE POSITIONING AND OBJECTIVES

Reports to: Sr Manager eSubmissions

No Direct Reports

Core Relationships:Submissions and other SR&D (Scientific Research & Development) divisions

Geographic Scope:US

No Travel Required

This role will support enterprise-wide regulatory strategies and advocacy efforts, particularly as they relate to regulatory approval of new products and marketing orders. Through strong leadership and technical expertise, this role supports Scientific & Regulatory Affairs (S&RA) by supporting the electronic submissions team to produce applications aligned with strategies for future market introductions. Specifically, the selected candidate will support electronic submission application projects by ensuring the accuracy and compliance of highly detailed regulatory documentation for electronic product submissions (e-submissions).

WHAT YOU WILL BE ACCOUNTABLE FOR

• Prepare documentation for product applications (e.g., Pre-Market Tobacco Product Applications and Modified Risk Tobacco Product Applications) to be electronically submitted to regulatory agencies
• Ensure quality standard of documents in accordance with agency review requirements and e-submission readiness
• Apply publishing processes to improve navigational elements such as bookmarks, hyperlinks, cross references, TOC creation and publishing audit processes
• Maintain various types of submission files through version tracking, database management, etc.
• Initiate and support continuous process improvement related to the delivery of regulatory services
• Partner/collaborate with various internal and external stakeholder groups
• Assist Sr. Manager and eSubmissions team in providing strategic and operational guidance, regulatory support and technical expertise to internal stakeholders in a manner consistent with the company’s objectives
• Maintain awareness of relevant federal guidance, particularly as related to electronic submissions

CAN THIS BE YOUR FUTURE ROLE?

• Are you familiar with FDA regulatory documentation requirements in the United States?
• Are you energized by working cross-functionally in a collaborative, fast-paced environment?

ESSENTIAL EXPERIENCE, SKILLS AND KNOWLEDGE

• Associate degree and/or minimum of 3+ years of experience in a Regulatory related environment, preferably performing
  e-submission readiness activities for electronic submissions
• Excellent written, communication, and interpersonal skills
• Strong attention to detail and accuracy in document review required
• Demonstrated capacity to quickly accumulate and apply broad, cross-functional business knowledge
• Demonstrated ability to manage and execute multiple projects often under heightened time constraints
• Strong project management with attention to detail, organizational skills, and computer skills
• Technical knowledge of US regulatory requirements for electronic submissions
• High competency with MS Office, Adobe Pro
• Experience using ToolBox® software is a plus
• Demonstrated ability to work both independently and as part of a team

WE ARE REYNOLDS AMERICAN—A member of the BRITISH AMERICAN TOBACCO GROUP

At Reynolds American, we are committed to our Purpose of creating A Better Tomorrow. This is what drives our people and our passion for innovation. See what is possible for you at REYNOLDS AMERICAN.

• Global Top Employer with 53,000 British American Tobacco employees across more than 180 markets
• Great Place to Work Certified
• Brands sold in over 200 markets, made in 44 factories in 42 countries
• Newly established Tech Hubs building world-class capabilities for innovation in four strategic locations
• Diversity leader in the Financial Times and International Women’s Day Best Practice winner
• Seal Award winner – one of 50 most sustainable companies

BELONGING, ACHIEVING, TOGETHER

Have you been on a career break for 18 months or longer? Are you ready to return to your career? If your answers to these questions is yes, we would love to hear from you. Regardless of why you took a break, we value you for all the skills you can bring to the workforce. Reignite your career, work flexibly, be part of a dynamic team and upskill yourself with on-the-job training and development support.

Collaboration, diversity and teamwork underpin everything we do here at Reynolds American. We know that collaborating with colleagues from different backgrounds is what makes us stronger and best prepared to meet our business goals. Come bring your difference!

SALARY AND BENEFITS OVERVIEW

Benefit Information

The following is a general summary of the competitive compensation and benefit plans we offer:

• 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
  • Company contributes an additional three percent to 401(k) whether employee participates or not
• Comprehensive health- and welfare-benefits package (including medical, dental, vision, and prescription drugs)
• Health Savings Account start-up contribution for employees who elect the high deductible health plan
• Flexible spending accounts for both Health Care and Dependent Care allowing employee to use pre-tax dollars to pay for qualified expenses during the calendar year
• Employee assistance program offering 8 free counselling sessions, per issue, each calendar year for employees and their dependents
• Company paid life insurance of 1x annual base pay ($50,000 minimum)
• Company paid accidental death or dismemberment insurance of 2x annual base pay ($50,000 minimum)
• Voluntary insurances offered at group rates: employee and dependent life insurance, AD&D insurance, critical illness, accident coverage, disability buy-up, and auto & home insurance
• Tuition reimbursement and student loan support
• Dependent Scholarship Programs
• Free confidential personal financial counselling service
• On-site health centers and 24/7 fitness centers at certain company locations
• A charitable giving matching grants program that enables employees to direct and double their donations to qualifying charitable organizations of their choice
• Health-care concierge service
• Volunteer service opportunities
• Extensive training opportunities
• Company vehicle for eligible employees
• Mobile phone allowance for eligible employees
• Paid Leave:
  • Sick and Personal Time (exempt employees may be excused with pay for brief absences; non-exempt employees receive up to 6 days)
  • Vacation (levels Below Senior Director receive 15 days (pro-rated during first year of service); Senior Director and Officers receive 25 days (pro-rated during first year of service)).
  • Holidays (Nine company recognized and two annual personal holidays to be used at the employee’s discretion)
  • Paid Parental Leave + temporary reduced work schedule opportunity.
  • Funeral Leave
  • Short-Term Disability Leave
  • Long-Term Disability Leave
  • Jury Duty Leave
  • Military Leave
  • Released Time for Children’s Education
  • Community Outreach Leave
  • Other paid leave benefits, as required by state or local law

Our organization offers a level of challenge, responsibility, and creativity for motivated employees who want to grow their careers. We are also committed to employing a diverse workforce and valuing different perspectives, experiences, and talents to improve the company's potential for optimally achieving its business objectives!

Reynolds American Inc. and its affiliated companies is an Equal Opportunity. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other status protected by law. Only applicants requiring reasonable accommodation for any part of the application and hiring process should contact us directly via email atTalentAcquisition@RJRT.com.