Business Analyst with experience in Clinical Content Management
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Job Location:
San Francisco, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
6 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Title: Business Analyst with experience in Clinical Content Management
Location: San Francisco CA -- Hybrid 3 days
We are seeking an experienced Business Analyst with strong domain knowledge in Clinical Content Management to support pharmaceutical product development. The role will focus on defining and implementing requirements for clinical content lifecycle automation including Clinical Study Reports (CSR) regulatory documents and protocol-related content.
Key Skill Requirements
- Collaborate with Clinical Development Regulatory Medical Writing and Quality teams to understand business processes and pain points across the clinical content lifecycle.
- Demonstrate strong understanding of clinical documents such as:
- Clinical Study Reports (CSR)
- Protocols and protocol amendments
- Investigator Brochures (IB)
- Efficacy and safety sections
- Regulatory submissions (IND NDA BLA CTA)
- Demonstrate Strong understanding of content processes including authoring co-authoring review redlining approval submission publishing and archival.
- Demonstrate Strong understanding of Clinical content on traceability auditability version control and compliance with regulatory guidelines (ICH GxP 21 CFR Part 11).
- Experience working with clinical content management platforms such as:
- Veeva Vault (RIM / Quality / Clinical / MedComms)
- Documentum
- Define functional requirements for workflows metadata models templates user roles access controls and document hierarchies.
- Support teams for optimization of content workflows to reduce cycle time and manual effort.
- Lead requirements gathering and documentation activities including:
- Business Requirements Documents (BRD)
- Functional Requirements Specifications (FRS)
- User stories and acceptance criteria
- Contribute to initiatives focused on automation of Clinical Study Reports and associated workflows.
- Exposure to regulated environments (GxP CSV Part 11).
- Experience working with medical writers and regulatory affairs teams.
- Familiarity with Agile or hybrid delivery models.
- Prior experience in pharma R&D IT transformation or digital clinical initiatives.
Key Skills
- SQL
- Agile
- Business Analysis
- Visio
- Waterfall
- Business Process Modeling
- Requirements Gathering
- User Acceptance Testing
- Business requirements
- SDLC
- Systems Analysis
- Data Analysis Skills
