Location: MA (3 days per week)
Duration: 6+ months (40 hours per week)
Start Date: ASAP
Job Title: Sr. Business Analyst – BLA/IND Filing
Client is looking for a senior Business Analyst who comes with significant Biologic experience for early development BLA/IND filing projects. Highlights of the position are as follows:
-Strong communication and organization
-Ability to work on multiple projects and own release and delivery timelines
– Process mapping for scientific and business processes
– Keeping stakeholders engaged, finding the need behind the request
-Experience working on project with internal and external stakeholders, experience comparing and selecting Commercial Off the Shelf solutions
-Experience managing deployment of Commercial Off the Shelf software solutions collaborating with infrastructure and IT teams
-Documenting user stories and pain points, experience collaborating with technical teams to define functional requirements
-Experience defining, measuring, and tracking performance indicators for scientific processes
• Required BA Experience: 7+ years
MUST HAVE BLA/IND Filing Support experience.
• Working knowledge of regulatory process, FDA filings for Investigational New Drugs (IND) and Biologics License Applications (BLA)
• Required BLA/IND Filing experience – 10+ years
Nice to have Early Development experience.
• Familiarity with SmartSheet specifically the Work Apps functionality
• Experience with mRNA science and/or early drug development processes is ideal
• Ability to derive scientific context from large data set
Nice to have Lab Automation experience.
• Knowledge on capabilities + limitations of Hamilton liquid handlers and related equipment
• Ability to understand the science behind assays and bring up suggestions for automation.
We require a standard 3 or 4 line highlight for each candidate in your email so we can see the following data points at a glance:
1. Years of experience as a BA/Product Owner
2. Years of life sciences experience
3. Years of specific domain experience (BLA/IND Filing support)
4. Anything else that is most relevant (certifications, relevant projects, etc,)
Business Analyst (BLA/IND Filing) (232807) MA