Overview Replimune's mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient's lives depend on it. We imagine a world where cancer is a curable disease. At Replimune, we live by our values: United: We Collaborate for a Common Goal.Audacious: We Are Bold and Innovative.Dedicated: We Give Our Full Commitment.Candid: We Are Honest With Each Other People are at the center of everything we do, and when it comes to our employees, we make it personal With a deep sense of purpose, an innovative and collaborative culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to contribute to the meaningful work we do which could impact the lives of patients. Join us, as we reshape the future.Job Summary: The Sr. Business System Analyst will act the primary technical contact and technical systems owner between Replimune and Veeva. Within Veeva GxP application portfolio, the Senior Business System Analyst will conduct needs and impact analysis on business requests to link programs, processes, and data throughout the Veeva landscape for optimal compliance and efficiency. The Senior Business System Analyst will consider how current organizational programs and systems will be impacted by future development both internally and by Veeva product changes. The ideal candidate will understand the overall company vision as well as compliance requirements in a GxP landscape and be able to relate this vision to specific business and system requirement details. The Senior Business System Analyst will be required to develop a plan and execute all activities to plan; including by not limited to facilitating interviews, requirements gathering, workshops with key stakeholders, identify/manage process improvements, facilitate governance to the Veeva landscape. The primary intent of this role is to analyze/define user requirements and translate requirements into clear and concise objectives. The Senior Business System Analyst is also required to understand and document plans, actions, and processes while ensuring GXP compliance. This position is based in our Woburn office and welcomes hybrid work! Local candidates are expected to be on-site 2 days per week. ResponsibilitiesKey responsibilities:
- Maintain the validation state of Veeva GXP applications with appropriate change management.
- Manage all Veeva operational/technical issues to resolution.
- Facilitate and moderate Veeva governance and oversight working group.
- Attend Veeva events to stay informed of product developments and changes.
- Build working relationships with Veeva account managers and engineers.
- Develop working relationships with existing Veeva systems owners.
- Follow GxP process to ensure regulatory compliance for Veeva systems.
- Participate in internal audits as required.
Other responsibilities
- Ability to plan, prioritize, monitor, facilitate, and manage multiple workstreams
- Strong written and oral communication skills.
- Service orientation, initiative, creativity, and organizational commitment.
- Track and aid with resolution of technical issues
QualificationsEducation:
- Bachelor's degree in Computer Science, Information Technology, Business Administration, or a related field or equivalent practical experience plus 3-5 years of experience.
Required Experience:
- Must 3-5 have Veeva experience in order to be considered
- Direct Hands-on experience with Veeva GxP applications
- Experience with 21 CFR 11
- Experience implementing and Managing Veeva vaults in a validated environment
- To be considered for this position, candidates must have experience in a similar role, and they must possess significant knowledge, experience, and abilities to successfully perform the responsibilities listed
- Relevant education and/or training will be considered a plus
About Replimune Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune's proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com. We are an Equal Opportunity Employer. #LI-Hybrid