Global Regulatory Systems Mana - new job in North Chesterfield, US

Global Regulatory Systems Mana
  • $150,000 - $170,000 per Hour
    HOUR
  • Permanent
  • North Chesterfield VA, US North Chesterfield CHESTERFIELD US
Job Ref: JO000131903
Sector: Clinical
Sub-sector: Quality
Date Added: 25 July 2022

Location: North Chesterfield, VA (Hybrid role, 3 days in office, 2 days remote)

Consultant Title: Global Regulatory Systems Manager

Duration: 6 Months to Perm opportunity

ESSENTIAL FUNCTIONS:

  • Ideal consultant will need regulatory environment/application. Skillset in IT. Project Management -In depth knowledge in Veeva and is subsidiaries; Veeva submission platform and Veeva RIMS
  • Regulatory operation experience and working with regulatory affairs within all elements of regulatory systems i.e.: Adobe, ISI toolbox, Iquivia RIMsmart
  • In depth knowledge on validation, writing scripts, working in conjunction with IT department
  • Project management skillset (MS Project is a plus), coordination, internal regulatory affairs, specs/requirements. Work with operation colleagues (strong interpersonal skills)
  • Good with timelines, management, coordination efforts, expectations
  • Working with a variety of people within the client operation or pharmaceutical industry

EXPERIENCE:

  • BS/BA Degree with 8+ years relevant experience and working knowledge in Pharmaceuticals.
  • Experience in working closely with IT Business Parnters internally
  • Experience in more than one area –
  • Managing complex high-impact RA systems projects from start to finish
  • Day-to-day administration of regulated systems
  • Business Analysis, Data Modeling, Information Architecture
  • Ability to effectively manage multiple priorities in a fast paced corporate environment.
  • Detail-oriented with a capacity to deliver accurate results.
  • Strong knowledge of control and management of regulatory-focused content, throughout the product lifecycle stages, SDLC methodologies and CFR Part 11 and Annex 11 compliance.
  • Expert in the use of Microsoft Office Suite (Word, Excel, Power Point, Project, Visio).
  • Good understanding of Regulatory Affairs.
  • Strong knowledge of business analysis, system design and producing quality documentation.
  • Strong knowledge of technologies such as SharePoint, Veeva (most of suites of platforms), EDMS, and/or off-the-shelf software products that support the Regulatory Affairs business.

BENEFITS:

  • Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes:
  • 3 weeks’ vacation plus floating holidays and sick leave
  • 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions discount and profit sharing contribution equal to 4% of your eligible pay
  • U.S. Employee Stock Purchase Plan- 15% Discount
  • Comprehensive Medical, Dental, Vision, Life and Disability coverage
  • Health and Dependent Care Flex Spending options
  • Adoption assistance
  • Tuition reimbursement
  • Leverage Concierge/personal assistance services
  • Voluntary benefits including Legal, Pet Insurance and Auto/Home coverage
  • Gym, fitness facility and cell phone discounts
  • Our Guiding Principles, Core Values and Vision provide a culture that unites and guides our employees.

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

#LI-TY1

SRGTalent https://www.srgtalent.com https://www.srgtalent.com/-/media/srg/1---new-website/logos/website-logo-all-padding-removed.png
26/08/2022 12:00:00
USD 150000.00 170000.00 Hour
Contact Consultant:
Tiahti Young

Submitting application, please wait..

Share location?

Do you want to share your location for better user experience ?