Business Analyst Pharma R&D

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The Position

Business Systems Analyst- Pharma R&D

Job description

The Business Systems Analyst is an active and self-sufficient contributor within their project or product this role you will analyze business requirements independently and translate them into detailed system specifications. You will be responsible for configuring systems planning and executing various levels of testing and designing automated systems including hardware and software compatibility. By providing direct consultation to users creating detailed documentation and offering technical assistance you will ensure seamless operations while considering both the short-term and long-term implications of your decisions.

The ideal candidate will possess a strong background in the pharmaceutical or biotechnology industry with experience working within Regulatory Affairs Clinical Operations or Pharmacovigilance / Safety team with a solid understanding on the E2E process flow across R&D. Additionally a proven track record of navigating the stringent requirements of GxP environments (GCP GMP GVP) and managing complex cross-functional data workflows is highly desirable.

Description of the area

Job Responsibilities

• Scope / (Content Leadership): Plays an active part within the project and/or product team. Provides constructive feedback seeks feedback for self reflects on own challenges and successes and actively supports others.

• Accountability/Problem Solving: Analyzes business requirements and translates them into system specifications. Configures system settings and options to meet user needs. Plans and executes unit integration and acceptance testing. Able to assess and communicate risks effectively.

• Stakeholder Management: Identifies and communicates with stakeholders in a straightforward manner. Considers both short-term and long-term implications in decision-making and adjusts rapidly in response to shifting priorities.

• Business / Technical ability: Acts as the strategic bridge between business stakeholders and technical implementation teams. This role provides expert consultation to users translates complex business needs into detailed actionable system specifications and ensures technical solutions deliver measurable business value.

• Business-to-Technical Translation: Act as the primary bridge between cross-functional business stakeholders and technical or operational implementation teams to deliver seamless digital capabilities.

• Lifecycle & Workflow Management: Oversee and optimize complex domain workflows including clinical data management Health Authority Q&A tracking dossier preparation or global safety case processing.

• GxP Compliance & Governance: Ensure all processes data exchanges and platform configurations adhere strictly to global regulatory guidelines data integrity principles and company standard operating procedures (SOPs).

• Cross-Functional Collaboration: Partner with global IT validation leads and system vendors to manage platform upgrades integrations and releases without disrupting business continuity.

Qualifications

Education / Experience

• Agile & Product Team Delivery: Demonstrated experience acting as an active self-sufficient contributor within cross-functional project or product teams driving deliverables independently under minimal supervision.

• Requirements Lifecycle Management: Proven capability to independently elicit and analyze complex business requirements translating them into detailed functional requirements user stories and technical system specifications.

• Continuous Learning & Collaboration: A track record of actively driving an independent professional development plan while contributing to internal knowledge-sharing initiatives mentorship and community of practice groups.

Technical Skills

• Solution Design & Compatibility: Strong capability to design automated system workflows and analyze cross-platform hardware and software compatibility to support business requirements.

• System Configuration & Customization: Proven experience hands-on configuring system settings business rules and application options to align precisely with user requirements and operational needs.

• Testing Strategy & Execution: Ability to plan coordinate and execute comprehensive testing cycles including unit integration and User Acceptance Testing (UAT) to ensure system reliability and validation compliance.

• Technical Documentation: Proficiency in authoring high-quality business requirements documents (BRDs) detailed functional/system specifications user stories and comprehensive process maps.

Additional Qualifications

• Industry Background: Strong experience in the pharmaceutical or biotechnology sector or life sciences consultancy working directly with Clinical Regulatory or Safety teams.

• Compliance & GxP: Proven track record of navigating regulated GxP environments (including GCP GMP and GVP standards).

• Technical & Platform Familiarity: Familiarity with industry-standard platforms is highly desirable (e.g. Veeva Vault RIM/Clinical/Safety Argus ArisGlobal or cloud-based health authority data networks).

• Analytical Problem Solving: Proven capability to analyze fragmented data workflows identify bottlenecks and architect streamlined compliant solutions.

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Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.