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

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.

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