Business Analyst (BLA/IND Filing) (232807) MA

Engineering Services | Life Sciences & Technology

Location: MA (3 days per week)

Duration: 6+ months (40 hours per week)

Start Date: ASAP

Job Title: Sr. Business Analyst – BLA/IND Filing

Job Description:
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

About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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