Negotiable
Outside
Remote
USA
Summary: We are looking for a detail-oriented Business Analyst specializing in R&D and Life Sciences to enhance strategic initiatives within the Research & Development function. The role involves collaboration with various teams to improve processes, support system implementations, and provide data-driven insights for drug and device development. The ideal candidate will have a strong background in life sciences and experience with relevant R&D systems. This position is remote and classified as outside IR35.
Key Responsibilities:
- Support strategic initiatives across the Research & Development function.
- Collaborate with cross-functional teams including scientists, clinical teams, regulatory affairs, and IT.
- Drive process improvements and support system implementations.
- Deliver data-driven insights to enable innovation and regulatory compliance.
Key Skills:
- Bachelor's degree in Life Sciences, Biotechnology, Bioinformatics, Computer Science, or related field (Master's preferred).
- Strong experience as a Business Analyst in the life sciences domain, with direct experience supporting R&D or scientific functions.
- Solid understanding of drug development or medical device lifecycle, including preclinical research, clinical trials, and regulatory submission processes.
- Experience with R&D systems such as ELN, LIMS, CTMS, Veeva Vault, or equivalent platforms.
- Knowledge of GxP, FDA, EMA, and other relevant regulatory frameworks.
- Strong communication, stakeholder management, and documentation skills.
- Proficient in process mapping (e.g., BPMN), requirements gathering, and testing coordination.
- Experience working in an Agile or hybrid Agile/Waterfall project environment (preferred).
- Familiarity with data visualization tools (e.g., Power BI, Tableau) and basic knowledge of SQL or scientific data formats (preferred).
- Exposure to FAIR data principles or data governance in a scientific context (preferred).
- Experience with global life sciences organizations or CROs is a plus (preferred).
Salary (Rate): undetermined
City: undetermined
Country: USA
Working Arrangements: remote
IR35 Status: outside IR35
Seniority Level: undetermined
Industry: IT
Business Analyst LifeSciences R&D
Job Summary:
We are seeking a highly motivated and detail-oriented Business Analyst with expertise in R&D and Life Sciences to support strategic initiatives across the Research & Development function. This role will work closely with cross-functional teams including scientists, clinical teams, regulatory affairs, and IT to drive process improvements, support system implementations, and deliver data-driven insights that enable innovation and regulatory compliance in drug/device development.
Required Qualifications:
- Bachelor's degree in Life Sciences, Biotechnology, Bioinformatics, Computer Science, or related field (Master's preferred).
- Strong experience as a Business Analyst in the life sciences domain, with direct experience supporting R&D or scientific functions.
- Solid understanding of drug development or medical device lifecycle, including preclinical research, clinical trials, and regulatory submission processes.
- Experience with R&D systems such as ELN, LIMS, CTMS, Veeva Vault, or equivalent platforms.
- Knowledge of GxP, FDA, EMA, and other relevant regulatory frameworks.
- Strong communication, stakeholder management, and documentation skills.
- Proficient in process mapping (e.g., BPMN), requirements gathering, and testing coordination.
Preferred Qualifications:
- Experience working in an Agile or hybrid Agile/Waterfall project environment.
- Familiarity with data visualization tools (e.g., Power BI, Tableau) and basic knowledge of SQL or scientific data formats.
- Exposure to FAIR data principles or data governance in a scientific context.
- Experience with global life sciences organizations or CROs is a plus.