Life Sciences BA Generalist (Contractor)

We are looking for a Life Sciences BA Generalist (Contractor) with strong experience in the pharmaceutical and life sciences industries to join our Solution Group as domain expert. In this part-time role, you will support presales and discovery activities, helping shape solutions that address client needs and align with industry-specific requirements.

What We’re Looking For:

• Business Analysis / Product Ownership: Experience as a Business Analyst or Product Owner working on software for pharmaceutical companies, biotech organizations, or Contract Research Organizations (CROs)
• Presales and Discovery: Experience in solution scoping, effort estimation, and proposal development
• Regulated Environments: Experience working in a GxP-regulated environment, with an understanding of GCP, FDA 21 CFR Part 11, audit trails, validation, and ALCOA+ data integrity principles
• Hands-on experience in at least one of the following areas: Clinical Operations (CTMS, eTMF, feasibility, patient recruitment, and RBQM); Clinical Data (EDC, eCOA/ePRO, IRT, and clinical data management); Real-World Data & Evidence (RWD/RWE); Pharmacovigilance / Drug Safety; Regulatory Affairs & Labeling; Quality Systems (eQMS); Manufacturing & Supply (GMP, MES, and serialization); R&D & Laboratory Informatics (LIMS and ELN); Commercial Systems & Patient Services
• Strong communication and collaboration skills, with the ability to work effectively with cross-functional teams
• English: Upper-Intermediate or higher

Responsibilities:

• Play a key role in presales activities, supporting solution design and client engagements
• Ensure proposed solutions and processes align with applicable regulatory requirements and industry best practices
• Identify client business needs, expectations, and challenges, translating them into clear business drivers and effective technical solutions
• Plan, conduct, and facilitate discovery workshops with clients and stakeholders
• Elicit, analyze, simplify, prioritize, and document business requirements
• Drive and coordinate discovery-phase activities, ensuring alignment between business needs and proposed solutions

Will Be a Plus:

• Life Sciences Platforms: Hands-on experience with Medidata, Veeva, Oracle Health Sciences, or IQVIA solutions
• Medical Devices / SaMD: Experience with regulated medical device software, including Software as a Medical Device (SaMD), or medical devices used in clinical trials
• Healthcare Interoperability: Experience with healthcare data exchange standards such as HL7 and FHIR, particularly in integrating EHR data into clinical trial systems