Life Sciences BA Generalist (Contractor) New

Binariks Inc.; United States; Remote; USD 83,000 - 124,000; Part time

Job summary

Binariks Inc. is seeking a Life Sciences BA Generalist (Contractor) for a remote, part-time role to support presales and discovery in the pharmaceutical and life sciences space.

The candidate should have strong Business Analysis or Product Ownership experience within pharma, biotech, or CRO software, with exposure to GxP-regulated environments and industry standards. The role emphasizes discovery workshops, requirement elicitation, and translating business needs into compliant technical

Qualifications

• Experience as a Business Analyst or Product Owner for software in pharma, biotech, CROs.
• Experience in solution scoping, estimation, and proposal development.
• Experience in a GxP-regulated environment with GCP, 21 CFR Part 11, audit trails, validation, and ALCOA+ data integrity.

Responsibilities

• Contribute to presales activities, assisting with solution design and client engagements.
• Ensure proposed solutions comply with regulatory requirements and industry best practices.
• Identify client needs and translate them into business drivers and technical solutions.
• Plan, conduct, and facilitate discovery workshops with clients and stakeholders.
• Elicit, analyze, and document business requirements; prioritize and align with solutions.
• Drive discovery-phase activities ensuring alignment between business needs and solutions.

Skills

Business Analysis / Product Ownership

Presales & Discovery

Regulatory GxP knowledge

Clinical Ops

Clinical Data

RWD / Evidence

Pharma regulatory

Communication skills

English proficiency

Job description

Life Sciences BA Generalist (Contractor)

Remote

We are looking for a Life Sciences BA Generalist (Contractor) with strong experience in the pharmaceuticalandlife sciencesindustries 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