Veeva Systems

Analyst - Computer Software Validation (Remote)

Raleigh, North Carolina, United States

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Healthcare, Enterprise SoftwareIndustries

Requirements

Candidates should possess at least one year of experience in computer software validation specifically for clinical trial software such as CTMS, CDMS, and eTMF, along with working knowledge of the software development cycle (SDLC) and Good Clinical Practice (GCP) guidelines, including 21 CFR Part 11 and EU Annex 11.

Responsibilities

The Analyst will participate in RTSM requirement gathering sessions with clients and team members, collaborate closely with Development and Project Management teams to ensure clear and testable requirements, develop and maintain CSV deliverables like requirements specifications, test scripts, and summary reports, manage validation testing cycles and issue resolution, maintain change control documentation, provide technical expertise in computer system validation and quality system requirements, and support customers in RTSM validation activities.

Skills

CSV

Clinical Trial Software

GCP

21 CFR Part 11

EU Annex 11

SDLC

Requirements Gathering

Test Script Development

Change Control

Validation Testing

Veeva Systems

Quality and regulatory software solutions provider

About Veeva Systems

Veeva Systems offers software solutions for quality, regulatory, and advertising claims management, focusing on consumer products and chemical companies. Their cloud-based platform provides visibility and traceability throughout the product journey, ensuring compliance with regulations and accelerating time-to-market. Unlike competitors, Veeva has specialized expertise in both the Life Sciences and Chemical sectors, allowing them to effectively address industry-specific challenges. The company's goal is to help clients efficiently bring safe and compliant products to market.

Key Metrics

Pleasanton, CaliforniaHeadquarters

2007Year Founded

$6.8MTotal Funding

IPOCompany Stage

Enterprise Software, Healthcare, Consumer GoodsIndustries

5,001-10,000Employees

Benefits

Parental leave

PTO

Free food

Health, dental, & vision insurance

Gym membership reimbursement

Risks

Manual processes in medtech content management risk compliance issues and market delays.

GenAI features in Vault CRM may face data privacy and security challenges.

Rapid product expansion could lead to integration challenges and customer dissatisfaction.

Differentiation

Veeva Systems specializes in cloud-based software for the life sciences industry.

The company offers a subscription-based model ensuring continuous updates and improvements.

Veeva's Vault CRM Suite connects sales, marketing, and medical for customer-centric engagement.

Upsides

Veeva Compass Patient platform supports patient journey analysis and market sizing.

GenAI features in Vault CRM enhance field productivity with contextual task automation.

Veeva's digital HACCP solution improves safety and efficiency in compliance processes.

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