Sr. Business Systems Analyst - Regulatory Science, R&D
Bluebird Bio, Cambridge, Massachusetts, USA
integrated product platforms with broad therapeutic potential
Senior Business Systems Analyst, R&D
Join bluebird bio’s passionate and collaborative team by contributing to the overall success of our novel gene therapy approach. bluebird bio seeks an outstanding Business Systems Analyst that will function primarily as partner to business process owners, and as an intermediary to the technical teams supporting them. We are interested in self-directed candidates who embrace the learning within the challenges, and who will thrive in a fast-paced, dynamic environment.
About the Role:
- Effectively partners with clients to analyze their business processes, identify gaps and pain points, then build and document user and system requirements to guide solutions selection. Work with the business process owners to develop project charters and plans to identify resources and establish reasonable target delivery dates and coordinate these to give projects the best chance of being delivered on time and within budget.
- Manage solution selection process, oversee contracting and negotiations with clients, internal legal and finance teams, and vendors.
- During implementation, work with external parties when necessary to analyze, define and document data and information flows impacting clinical operations and data management.
- Post-implementation, work in concert with the user community to actively manage and optimize solutions and processes through the system lifecycle.
- Initial focus is specifically on solutions related to the Regulatory Operations area. This will include but not be limited to, issues impacting Regulatory Information Management (RIM), Publishing, and various Document Template / Formatting tools.
- Familiarity with the following solution platforms: Veeva Vault, Acuta / IQIVA RIM SMART, DocLabel, Lorenz eValidator, DocX tools, and PleaseReview.
- 3 - 6+ years overall experience in drug development with at least 3 years program management experience in the biopharmaceutical industry. Experience in Regulatory Operations / Sciences highly preferred.Program Management experience in late clinical stage or commercial stage company is highly preferred. Experience in rare diseases is preferred.
- Outstanding communication, analytical, and organizational skills
- Proven ability to manage scientifically and operationally complex programs
- Proven ability to balance the strategic needs of the program with tactical day-to-day activities
- Strong interpersonal skills with the ability to motivate others, influence without authority, and negotiate conflict situations
- Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders, as well as all members of the IT Organization.
- A passion for addressing the critical unmet medical needs of patients
- Willingness to embrace and demonstrate the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
About Bluebird Bio
About us We are leading the gene therapy revolution. Our integrated product platforms encompass gene therapy, cancer immunotherapy and gene editing – providing us with the potential to treat, and hopefully cure, a broad range of serious diseases. We have a lot of energy, and it’s not just the abundance of coffee that keeps us going. Find out what sparks our excitement and inspires us every day.
Want to learn more about Bluebird Bio? Visit Bluebird Bio's website.
Great Prices. Better Cars. Shipped to You.