Quality Engineered and Compliance Assured
BA Regulatory Business Analyst
Location
Oregon
Posted
69 days ago
Salary
0
Seniority
Senior
Job Description
BA Regulatory Business Analyst
RxCloud
• Efficiently lead conversations, gather requirements from Business • Understand concerns, identify risks, communicate promptly • Represent IS Regulatory Affairs workstream to broader Program team • Provide project updates/statuses on a regular basis • Ensure document/data imported/exported into/from Veeva RIM system • Coordinate with migration team for data migration/export • Create a project plan, manage and execute it • Work with Onsite-Offshore team to ensure delivery of work on time • Work with multiple vendors to execute the project
Job Requirements
- Business Analyst with Regulatory Affairs experience
- Merger & Acquisition experience
- Regulatory data migration experience
- Ability to manage and execute projects
- Ability to gather requirements
- Collaborative and efficient communicator
- Proven ability for creative thinking
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• Conduct data analysis to identify trends, patterns, and insights • Assist in developing and implementing data-driven strategies and initiatives • Collaborate with cross-functional teams to gather and analyze business requirements • Support the Senior Business Analyst in preparing reports and presentations • Monitor and evaluate the performance of key business metrics • Assist in the development and maintenance of data models and databases • Contribute to process improvement initiatives to enhance operational efficiency
• Conduct in-depth analysis and document business needs to develop comprehensive functional specifications. • Improve business operations and streamline technology interactions for enhanced efficiency. • Engage with stakeholders across various functions to ensure the development of integrated solutions. • Maintain accurate project artefacts, including specifications and workflow diagrams, to ensure clear project tracking and communication. • Lead requirement gathering and stakeholder engagement workshops to capture and understand business needs. • Work collaboratively to design solutions that align with and support business goals. • Oversee the creation and execution of test cases to ensure the effectiveness and quality of implemented solutions.
Configuration Specialist
Lindus HealthWe're a next gen CRO running end-to-end clinical trials for health and biotech pioneers.
🍊Our mission We're powering biology's century with radically faster, more reliable clinical trials. Every new treatment needs clinical trials to prove safety and efficacy, but today's infrastructure is stuck in the past- driving up cost, causing delays and ultimately meaning new treatments don’t get to patients. We're fundamentally changing that- not just being a "better CRO," but transforming how people think about developing new treatments, so patients can access breakthrough treatments faster. Our impact speaks for itself: Since March 2021, we've powered 100+ clinical trials involving tens of thousands of patients. We recently raised a $55M Series B from Balderton Capital, alongside backing from Creandum, Firstminute, Seedcamp, and Visionaries. 🍊What's it like to work here? When you join us, you’ll experience: - High-Impact, Mission-Driven Work: Lindus Health is disrupting an outdated industry, giving you the chance to directly improve patients’ lives and see tangible results from your work. - Fast-Paced Growth & Ownership: We recognise hard work and outcomes over anything else. You’ll take on real responsibility, work across different areas, and actively shape the company’s success. - Collaborative, No-Ego Culture: Work with smart, driven people in a supportive and informal environment. At Lindus we break down silos, fun is a core value, and creativity is encouraged. Ready to power biology's century? We'd love to hear from you. 🍊 About the role We're looking for a Configuration Specialist to help us accelerate our mission to power biology's century with radically faster, more reliable clinical trials. This is a hands-on technical role within our Deployment function, the team responsible for building and delivering clinical trials on Citrus, our proprietary platform. You will own the setup and testing of studies, working from detailed design specifications to produce something that works reliably for the people running and participating in the trial. No two studies are the same, and the work you do directly affects how quickly a trial gets off the ground and how reliably it runs. 🍊 About you We'd like to hear from you if... - You have a technical background, whether through a degree in a relevant field or hands-on experience in software, data, or systems work - You are comfortable working from detailed specifications and have a clear instinct for when to get on with it and when to ask - You are precise and thorough by nature, and comfortable maintaining that standard in a fast-moving environment - You keep track of multiple things at once without things falling through the cracks - You have some experience in a regulated or quality-focused environment, whether in healthcare, finance, or elsewhere You belong here! If your experience and interests match with some of the above, we want you to apply. 🍊 What you'll focus on - Setting up studies on Citrus based on approved specifications, covering data collection forms, participant schedules, logic rules, and user access - Running automated checks to make sure everything in the build matches what was agreed before a study goes live - Coordinating testing with internal teams and sponsors, writing test scripts, working through issues, and making sure everything is resolved before sign-off - Making approved changes to live studies and keeping things accurate and compliant as trials evolve - Coordinating go-live activities and confirming everything is running correctly before a study is declared live 🍊What We Offer (US) We believe in rewarding the people who are building the future of clinical research. Financial & Growth: - Competitive salary plus meaningful equity - you'll own a piece of what we're building - $2,000 annual Learning & Development budget for courses, certifications, and conferences - 39 days annual leave (27 days PTO + 11 federal holidays + 1 James Lind Day) Health & Wellbeing: - $800 monthly employer contribution for insurance coverage (via Trinet PEO) - $40 monthly wellness allowance with flexibility on how to spend this, including opting in to a company private health insurance or wellhub membership. - Access to gym and retail discounts through Happl Culture & Connection: - Monthly lunch vouchers for remote team members - Regular company events and team gatherings (both virtual and in-person) - Charity partnerships and volunteering opportunities with Forward Trust - Work with a team that's genuinely changing healthcare for the better 🍊Our Hiring Process We believe hiring should be transparent, respectful of your time, and give you a real feel for what Lindus Health is like. Here's what to expect: Criteria a 15 minute critical thinking and problem solving test Introduction with Sophie, Talent Lead (30 mins) Get to know each other, discuss the role, and answer any questions about Lindus Expertise interview with Elaine AD deployment (30 minutes) Technical interview with with a Solutions Architect (Connor, Tatiana, or Shreya) and a Solutions Engineer (Fabiha, Roman, Sara or Nate) (60 minutes) Values interview with a co-founder and Veronica VP Deployment (30 mins) - A chance to get to know each other and explore how our values align We will only contact you from lindushealth.com email addresses. Please check the spelling of emails which appear to come from Lindus Health carefully before responding. We will never ask for your financial information over email. We are an equal opportunity employer committed to building a diverse and inclusive workforce. We evaluate all candidates based solely on their skills, experience, and qualifications relevant to the role. We do not discriminate on the basis of race, ethnicity, religion, gender, gender identity, sexual orientation, age, disability, veteran status, or any other legally protected status
Senior Business Analyst
CiklumAt Ciklum, we are always exploring innovations, empowering each other to achieve more, and engineering solutions that matter. With us, you’ll work with cutting-edge technologies, contribute to impactful projects, and be part of a One Team culture that values collaboration and progress. As one of Ukraine’s largest IT companies and a top employer recognized by Forbes, we’ve spent over 20 years delivering meaningful tech solutions. We proudly support diverse talent and military veterans, recognizing their unique skills and perspectives they bring to shaping the future.
Ciklum is looking for a Senior Business Analyst to join our team full-time in Ukraine. We are a custom product engineering company that supports both multinational organizations and scaling startups to solve their most complex business challenges. With a global team of over 4,000 highly skilled developers, consultants, analysts and product owners, we engineer technology that redefines industries and shapes the way people live. About the role: As a Senior Business Analyst, become a part of a cross-functional development team working for one of the Ciklum’s client who develops a system designed to enhance learning, streamline school operations, and connect students, teachers, and parents in a unified digital environment. It provides real-time academic insights, and seamless integration with key educational tools Responsibilities: - Ensure stakeholders' engagement and effective collaboration - Plan, estimate, and perform Business Analysis activities within all SDLC stages - Define business needs and objectives - Define the most applicable elicitation approach and use appropriate techniques and ensure effective usage of techniques - Work with all requirements types throughout the whole life cycle: from the idea to the acceptance and maintenance. Ensure requirements quality on the project - Model requirements by using the most applicable notation according to the project needs - Define Information Architecture for project documentation within the project - Define or contribute to the solution roadmap definition - Define and manage the solution scope to avoid scope creep - Manage the backlog: from the definition of "how" to its execution, perform backlog prioritization and refinement - Define Change management procedure - Collaborate closely with the development team - Ensure requirements quality on the project - Facilitate Agile ceremonies according to the chosen development methodology and ensure their effectiveness - Define Business Analysis approaches and processes from scratch and implement ongoing improvements to the existing ones Requirements - Proven ability to work with different groups of stakeholders along with experience in setting up stakeholder management approach - Comprehensive experience in setting up Business Analysis processes and approaches (in elicitation, decomposition, modeling, documentation, traceability, prioritization, and change management) - Vast experience in setting up requirements life cycle management - High proficiency in requirements documentation, its structure definition, and templates creation - Solid experience in UML and BPMN modeling (and ability to adjust modeling approach according to the project context) - Advanced knowledge of how to manage a solution roadmap and experience in its definition (or contribution, at least) - Expertise in product scope management and backlog management - Solid knowledge of Business analysis techniques and best practices - Experienced and flexible Agile practitioner focused on delivering value - Communication is a key. You speak and write in English fluently or at least at an upper-intermediate level - Able to express ideas, thoughts, and questions simply, concisely, and in a structured way - Accountable for the own scope of work and follow the "said and done" principle - Eager to learn and grow: curios, keen to constant self-development - Proactive in efforts to deliver results according to expectations, as well as keen to suggest new ideas, looking for alternative solutions What`s in it for you? - Strong community: Work alongside top professionals in a friendly, open-door environment - Growth focus: Take on large-scale projects with a global impact and expand your expertise - Tailored learning: Boost your skills with internal events (meetups, conferences, workshops), Udemy access, language courses, and company-paid certifications - Endless opportunities: Explore diverse domains through internal mobility, finding the best fit to gain hands-on experience with cutting-edge technologies - Flexibility: Enjoy radical flexibility – work remotely or from an office, your choice - Care: We’ve got you covered with company-paid medical insurance, mental health support, and financial & legal consultations About us: At Ciklum, we are always exploring innovations, empowering each other to achieve more, and engineering solutions that matter. With us, you’ll work with cutting-edge technologies, contribute to impactful projects, and be part of a One Team culture that values collaboration and progress. As one of Ukraine’s largest IT companies and a top employer recognized by Forbes, we’ve spent over 20 years delivering meaningful tech solutions. We proudly support diverse talent and military veterans, recognizing their unique skills and perspectives they bring to shaping the future. Want to learn more about us? Follow us on Instagram, Facebook, LinkedIn. Explore, empower, engineer with Ciklum! Interested already? We would love to get to know you! Submit your application. We can’t wait to see you at Ciklum.




