Job Title: Lead - Aggregate Reporting Employment Type: Full-time Work Type: Remote About ClinChoice: ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis. Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, the United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally. We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision. Primary Responsibilities: Responsible for authoring Aggregate Safety Reports (including but not limited to PBRER/PSUR, ACO, DSUR, PADER, CAR, RMP, Ad-hoc safety reports for medicinal and non-medicinal products and EU-MDR PSUR, PMSR, PMSP, and PRER reports for medical devices, and Cosmetovigilance reports for Cosmetic products for submissions to various health authorities as per the requirement). Plan report-specific timelines, identify relevant stakeholders, request calls for contributions, and coordinate with various stakeholders for obtaining relevant data for the preparation of aggregate safety reports. Review the safety data (including the seriousness and expectedness assessments of events, as may be necessary) as per the agreed strategy and sponsor’s conventions and verify the correctness and completeness of contributions received from stakeholders. Perform aggregate review of post-marketing cases received in global databases and assess whether the cases alter t
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Job Description: Help guide report strategy, help determine important safety concerns and review medical and medical safety content that will be included or discussed in the report, including but not limited to safety signals, health authority requests, safety-related literature, adverse event case reviews, benefit-risk assessments, and overall medical assessments and conclusions. Work in collaboration with contributing team members, particularly with the reports assigned to the Global Risk Assessment and Safety Physician. Review all stages of the report that are assigned during the report authoring process, record their recommended revisions, and indicate completion of their reviews in the corresponding systems. Key Responsibilities: Provide medical and scientific judgment in the evaluation of data pertaining to the efficacy and safety of Client products including, but not limited to, PBRER-PSURs and benefit-risk evaluations Review and contribute to strategy discussions, including determination of the important safety concerns and review of draft/final data, HA feedback topics, signals, and benefit-risk evaluation. Coordinate with Global Risk Assessment and Safety Physicians regarding PBRER steps and hand-offs and collaborate with other members of the report authoring team. Review the drafts and final reports as assigned and provide feedback, which may include pre-initial, drafts, drafts, final drafts, and final reports as assigned. Experience/Qualifications: Requirement: Medical Physician Technical Skills: the ability to analyze, interpret, and present complex data in a concise and understandable scientific manner, both orally and in written format, is essential. Attention to detail: diligence in record-keeping and records organization, ability to manage high workload and critical issues, computer literate and proficiency in MS Office applications. Interpersonal skills: team player, displays initiative, strong communication, and presentation skills. I
Responsibilities: Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines. Develop SDTM specifications and generate SDTM datasets using SAS; Develop ADaM,specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan; Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts; Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) Create electronic submission packages to FDA, e.g., define.xml or define.pdf following FDA guidelines with no supervision. Expert-level in analyze information and develop innovative solutions to programming and data analysis challenges; Serve as point of contact (POC) of programming with statisticians for statistical input and analysis interpretation; Follow and reinforce regulatory agency requirements during daily job. Serve as a programming team lead and contribute to department initiatives. Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams; Review draft and final production deliverables for project to ensure quality and consistency. Work with global team or sponsors to coordinate project deliverables, timelines and resources. Skills and Responsibilities: Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines with 5+years of clinical programming experience. Proven knowledge and training in high level computing languages such as. SAS, C/C++, Java, R, Python, MATLAB and SQL. Database programming experience is a plus. Expert-level in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members. Expert level in applying concept in Artificial Intelligence and Machine Learning in real world. In-depth knowledge of ICH, Good Clinical Practices, Clinical research, Clinical tria
Responsibilities: Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines. Develop SDTM specifications and generate SDTM datasets using SAS. Develop ADaM specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan. Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts. Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE). Create electronic submission package to FDA, e.g., define.xml or define.pdf following FDA guidelines with minimum supervision. Proficient in analyze information and develop innovative solutions to programming and data analysis challenges; Support the point of contact (POC) of programming with statisticians for statistical input and analysis interpretation Follow and reinforce regulatory agency requirements during daily job. Serve as a programming team lead and contribute to department initiative. Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams. Review draft and final production deliverables for project to ensure quality and consistency. Skills and Qualifications: Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines with at least 4+ years of clinical programming experience. Proven knowledge and training in high level computing languages such as. SAS, C/C++, Java, R, Python, MATLAB and SQL. Database programming experience is a plus. Proficient in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members. Proficient in applying concepts in Artificial Intelligence and Machine Learning in the real world. In-depth knowledge of ICH, Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology. Good understa
JOB DESCRIPTION Responsibilities: Lead the Corporate System Project Specialist and responsible for the day-to-day operations of the ERP system. Collaborate closely with international cross-functional teams across multiple entities and system developers to identify improvement opportunities for the Microsoft Dynamics 365 ERP system and other company-wide applications. Analyze business requirements, develop functional specifications, prepare design documentation, and coordinate change requests, service requests, and budget alignment/approvals. Manage the full system project lifecycle, including project kickoff, planning, system issue tracking, timeline management, testing coordination, deployment, and implementation. Oversee testing activities and release schedules to ensure the successful delivery of system enhancements. Manage ERP timesheet operations and resource planning support. Monitor the company-wide timesheet and resource planning processes to ensure satisfactory completion and approval rates each month. Continuously evaluate and optimize timesheet management processes and training programs. Manage ERP user permissions and oversee the development, maintenance, and review of system-related standard operating procedures. Oversee issue tracking, resolution, and ongoing support for company-wide ERP system. Lead and facilitate ERP project meetings with stakeholders at all organizational levels. Design, develop, and deliver company-wide application training programs, including monthly ERP timesheet training for new hires, line managers, and project functional leads. Evaluate, initiate, and lead cross-functional standardization and automation initiatives that drive continuous business process improvement and operational efficiency. Skills and Qualifications: Bachelor’s degree or higher in computer science, science or a related field. Minimum of 5 years of relevant work experience. Strong written and verbal communication skills, with excellent analytical and problem-
About Us SharkNinja is a global product design and technology company, with a diversified portfolio of 5-star rated lifestyle solutions that positively impact people’s lives in homes around the world. Powered by two trusted, global brands, Shark and Ninja , the company has a proven track record of bringing disruptive innovation to market and developing one consumer product after another has allowed SharkNinja to enter multiple product categories, driving significant growth and market share gains. Headquartered in Needham, Massachusetts with more than 4,100 associates, the company’s products are sold at key retailers, online and offline, and through distributors around the world. AI at SharkNinja At SharkNinja, we’re building an AI-native culture. We’re not waiting for the future; we’re creating it. Our people are expected to experiment boldly, adopt new tools, and continuously raise what’s possible to create meaningful impact for our consumers. If you believe the best way to do your job hasn’t been invented yet, you’ll fit right in. Senior UX Designer - DTC Leeds or London (In office 3 days/week) About the role SharkNinja is seeking a strategic, highly skilled Senior UX Designer to join our Global Digital Store Centre of Excellence. This role will be instrumental in shaping and delivering best-in-class user experiences across our global direct-to-consumer (DTC) websites. As a Senior UX Designer, you will combine strategic UX thinking with hands-on design craft, leading the end-to-end experience from research and insight through user flows, wireframes, prototypes and high-fidelity UI. You will help define global UX principles while ensuring experiences are grounded in customer needs, business objectives and measurable performance. You’ll partner closely with Product, Engineering, Creative, Marketing, CRO, Analytics and r
WHO WE ARE: Zinnia is the leading technology platform for accelerating life and annuities growth. With innovative enterprise solutions and data insights, Zinnia simplifies the experience of buying, selling, and administering insurance products. All of which enables more people to protect their financial futures. Our success is driven by a commitment to three core values: be bold, team up, deliver value – and that we do. Zinnia has over $180 billion in assets under administration, serves 100+ carrier clients, 2500 distributors and partners, and over 2 million policyholders. WHO YOU ARE: As Senior Product Manager for Case Management, you will own the product area that moves insurance cases through their lifecycle — from new-business intake and requirements orchestration through underwriting, issuance, and placement. You will lead the product life cycle for this domain, partner closely with Engineering, and work across Zinnia’s Product Organization to keep the case-management experience aligned with company strategy while delivering measurable value to carriers, distributors, and policyholders. WHAT YOU’LL DO: Own the product roadmap and lifecycle for Zinnia’s case-management capabilities across the new-business and underwriting workflow - intake, requirements gathering, status tracking, and case placement - spanning distributor and carrier touchpoints on our platforms. Lead technical discussions with Engineering teams and manage technical and business requirements end to end. Partner with cross-functional teams to ensure product requirements are met, evaluate product performance, and transition features from development to commercialization. Define delivery and deployment timelines for new product, feature, maintenance, and corrective/service-pack releases. Ensure the technology and architectural roadmap aligns with and supports the product and business roadmap. Act as a customer liaison on technical matters related to product integration, custom development, and requ
About Energy CX: Energy CX is redefining the energy brokerage industry as the fastest-growing player in the US. By bringing cutting-edge technology, advanced analytics, and innovative solutions, we are disrupting a space that has operated in the dark for too long. Why Energy CX? Entrepreneurial and ambitious culture with a great team oriented environment Fastest growing energy broker in the country One of the fastest growing companies in Chicago Recognized by Fortune and Great Places to work US Named on Inc 5000’s list of America’s fastest growing companies Compensation Year 1 Expected Earnings → $115,000 to $200,000. The expected salary range above may vary based on qualifications and experience. Title: Senior Product Manager, Customer Platform About this Job We're looking for a Senior Product Manager to own our customer-facing energy purchasing and tracking platform during a critical high-growth phase. You'll define and drive the vision for turning that platform into an interactive, data-rich experience — think Bloomberg Terminal or Robinhood — that gives clients real-time visibility and control over their energy purchasing decisions. This is a flagship customer-facing bet, and you'll be the senior product voice shaping it end to end. What You'll Do Own the product roadmap and vision for the customer-facing platform, translating energy purchasing and tracking into an interactive, real-time interface Partner with Engineering, Design, and Quantitative Strategy to define data visualizations, live pricing displays, and interactive tools that make complex energy market data intuitive for clients Gather requirements directly from clients, Sales, and Customer Success to identify what drives engagement and decision-making on the platform Write detailed product requirements and specs, and work closely with engineering to ship features that measurably improve client engagement and retention Define and track success metrics (engagement, retention, feature a
Senior Product Manager, Robotics & Autonomy What we're doing isn't easy, but nothing worth doing ever is. At Diligent Robotics, we envision a future powered by robots that work seamlessly with human teams. We build artificial intelligence that enables service robots to collaborate with people and adapt to dynamic human environments. Our robots operate every day in hospitals, helping healthcare staff spend less time on routine work and more time caring for patients. Operating a real-world fleet gives us something few robotics companies have: continuous customer feedback and operational data that directly shapes the next generation of Physical AI. We're looking for a Senior Product Manager, Robotics & Autonomy to define and execute the product strategy for some of the most critical capabilities in our robotics platform. You'll work at the intersection of robotics, autonomy, AI, and software engineering to translate business priorities, customer needs, and technical opportunities into a clear product roadmap that drives measurable outcomes. This role is ideal for someone who understands complex autonomous systems and enjoys working alongside world-class engineers to bring ambitious technology from concept into production. Responsibilities Own the product strategy and roadmap for key Robotics and Autonomy initiatives, balancing customer impact, technical feasibility, and long-term platform investments. Define product requirements for autonomy, navigation, perception, fleet intelligence, simulation, and robotics platform capabilities. Partner closely with Engineering, AI, Robotics, Customer Success, Operations, and Leadership to align priorities across the organization. Translate customer feedback, fleet telemetry, and operational insights into product decisions that improve robot performance, reliability, and user experience. Prioritize investments using data, customer value, technical complexity, and business impact. Drive cross-functional execution from concep
Hyliion is committed to creating innovative solutions that enable clean, flexible and affordable electricity production. The Company’s primary focus is to develop distributed power generators that can operate on various fuel sources to future-proof against an ever-changing energy economy. Job Purpose The Senior Manager, Manufacturing Engineering owns the manufacturing engineering function across Hyliion's Cedar Park, TX headquarters and primary production site and its Milford, OH R&D operations. The role is the bridge between the engineering design of the KARNO Power Module and the scalable, repeatable production system required for commercial ramp, defining and driving the processes, tooling, documentation, and infrastructure that transform KARNO from a highly engineered prototype into a manufacturable product. This is a player-coach role: the incumbent builds and leads a team of manufacturing engineers while remaining personally hands-on in the most challenging production problems. AI at Hyliion At Hyliion, AI is core to how we work. We equip every team member with leading AI tools and count on you to use them — to move faster, solve harder problems, and help us realize the full potential of KARNO technology for the world. Duties and Responsibilities Productionization: translate engineering designs into manufacturable, repeatable, and scalable production configurations across both sites, aligned to the commercial ramp roadmap. Tooling and process development: design, develop, and qualify manufacturing tooling, fixtures, and processes that support quality, efficiency, and volume scalability. Manufacturing documentation: own PFMEAs, control plans, work instructions, SOPs, and MBOMs, keeping them accurate, current, and accessible to the production floor. Lean and material flow: define and implement standard work, material flow, and handling strategies that increase throughput, reduce waste, and prepare the factory for
Hyliion is committed to creating innovative solutions that enable clean, flexible and affordable electricity production. The Company’s primary focus is to develop distributed power generators that can operate on various fuel sources to future-proof against an ever-changing energy economy. Job Purpose The Senior Manufacturing Engineer serves as the senior technical authority for assembly process and equipment design within the Industrialization team. This position designs the assembly lines, fixtures, and material flow systems that convert KARNO prototype and development builds into repeatable, scalable production operations — and then systematically removes waste, labor content, and variation from those operations. Working closely with industrialization leadership, design engineering, production, quality, and supply chain, the Senior Manufacturing Engineer owns the most complex assembly value streams end to end: line and station design, fixture and tooling design, material presentation and handling, process qualification, and continuous waste reduction. This position sets the technical standard for how assembly processes are designed and documented at Hyliion, provides mentorship and design review for other manufacturing engineers, and is accountable for measurable improvement in cycle time, first-pass yield, labor content, and ergonomics across the assembly areas. AI at Hyliion At Hyliion, AI is core to how we work. We equip every team member with leading AI tools and count on you to use them — to move faster, solve harder problems, and help us realize the full potential of KARNO technology for the world. Duties and Responsibilities Assembly Line and Cell Design : Design assembly lines, cells, and workstations for KARNO core, module, and subassembly operations. Establish work sequencing, balance work content to takt, define station layouts and footprints, and design lines that accommodate planned rate increases rather t
Hyliion is committed to creating innovative solutions that enable clean, flexible and affordable electricity production. The Company’s primary focus is to develop distributed power generators that can operate on various fuel sources to future-proof against an ever-changing energy economy. Job Purpose The Senior Strategy & Supply Chain Associate is responsible for proactively assisting in the development of sourcing strategies that are aligned with business and program needs and then driving execution of those strategies while ensuring quality, delivery, and cost targets are exceeding expectations. Duties and Responsibilities Strategic Problem-Solving: Apply a structured, hypothesis-driven approach to diagnose complex supply chain challenges, identify root causes, and develop data-backed solutions. Data Analysis and Modeling: Conduct quantitative analysis using large datasets from our ERP and supply chain data. Develop and maintain analytical models to optimize key supply chain metrics such as inventory levels, lead times, and product economics. Process Optimization and Redesign: Lead high-impact projects to re-engineer core supply chain processes, leveraging best practices to drive significant improvements in efficiency, cost, and resilience. Cross-Functional Collaboration: Serve as a trusted advisor to internal stakeholders in Engineering, Finance, and Operations. Effectively communicate complex analyses and recommendations to senior leadership, fostering alignment and driving execution. Performance Management: Design, implement, and monitor key performance indicators (KPIs) and dashboards to track supply chain health and project performance. Provide regular, insightful reports to management on progress against strategic objectives. Supplier and Sourcing Strategy: Collaborate with the Procurement team to analyze supplier capabilities, assess market dynamics, and develop commodity and category strategies that align with bot
About StarRez StarRez is the global leader in student housing software, providing innovative solutions for on and off-campus housing management, resident wellness and experience, and revenue generation. Trusted by 1,400+ clients across 25+ countries, StarRez supports more than 4 million beds annually with its user-friendly, all-in-one platform, delivering seamless experiences for students and administrators. With offices in the United States, Australia, the UK, and India, StarRez blends the robust capabilities of a global organization with the personalized care and service of a trusted partner. The Role: We are looking for a Senior Quality Engineer - AI to help shape how StarRez evaluates, validates, and improves AI-powered product experiences. You will play a pivotal role in elevating our quality practices for AI-powered product experiences and tooling. You will be a product expert within our engineering organization, deeply understanding workflows and customer outcomes. This role will balance hands-on individual contributor responsibilities with leading, influencing, and coaching your peers. You’re someone who is passionate about seeing systems holistically and is eager to drive the highest standards of accuracy, safety, usefulness, and reliability. You will help define what "good" AI output means for StarRez, build repeatable evaluation systems, coach reviewers and subject matter experts, and turn subjective feedback into measurable product improvement. You will work at the intersection of AI engineering, product, and domain knowledge — partnering with engineers, product managers, and SMEs to raise the bar on how StarRez evaluates, monitors, and improves AI tools. Key Responsibilities: Lead or contributed to end-to-end AI quality and evaluation strategy for product experiences involving LLMs, RAG, prompts, tool-use, or agent workflows. Provided quality-focused input during ticket grooming, discovery, and feature discussions, with clear guidance on testability, ob
NMI is looking for a driven, high-performing enterprise sales professional to join our fast-growing fintech. This is a senior individual contributor, high impact role for a self-starter — someone who thrives on building pipelines, leading executive-level conversations, and consistently exceeding quota. You'll play a key role in NMI's growth — selling our API-first money movement and open banking solutions directly to enterprise and mid-market clients, all from wherever you work best. About NMI NMI, a global leader in payment technologies, allows software and sales professionals to deliver payment innovations to their clients without having to build payment expertise in house. NMI enables our partners with choice, and challenges the one-size-fits-all approach to payments. You've probably used NMI in the last 24 hours without even realizing it. We're the platform that powers success for innovative tech created by SMBs, entrepreneurs and fintech startups. We're creative problem solvers who help visionaries smash through boundaries and think beyond what's possible so they can think about what's next. But we're not just built for the tech savvy. We democratize the latest payments technology so that everyone can realize the benefits of easy payments across the full spectrum of commerce. Our mission is to use our expertise to enable more payments, in more ways and more places. We provide ISOs, Fintech Innovators and Technologists the freedom to focus on what they do best, liberating them from restricted payment solutions and giving them access to the latest payment technology now and in the future. How We Work - Our Core Values Be a Good Person, It's Simple. We treat everyone fairly and with respect. We lead with kindness, humility and integrity. We take the time to understand each other and our customers. And we serve with care, because customers are never a transaction, and always our focus Align, Trust & Go. We debate openly, listen carefully and challenge thoughtfu
At Qualia, we've built the leading B2B real estate technology that transforms the home buying and selling experience into a simple, secure, and enjoyable process. Our SMB and Enterprise products bring together users from across the real estate ecosystem---homebuyers and sellers, lenders, title and escrow agents, and real estate agents---onto a single shared digital closing platform, providing greater clarity and transparency to real estate transactions. Today, through our business customers across the country, millions of consumers use Qualia to close on homes every year. WHAT YOU'LL WORK ON The FP&A team at Qualia is the analytical engine of the Finance organization. We own the company's planning and forecasting processes, serve as trusted business partners to functional leaders, and produce the financial insights that inform our most important strategic decisions, all in an environment where AI is actively reshaping how we work. As a Senior Manager of FP&A, you will be a central force in shaping how Qualia plans, forecasts, and makes decisions as we scale. You will own high-impact analytical workstreams end-to-end, serve as the go-to financial partner for senior functional leaders, and help set the direction for how the FP&A function evolves, from the models we build to the processes we run to the way we leverage AI to work smarter. This is a high-visibility individual contributor role with direct exposure to executive and C-level audiences. RESPONSIBILITIES Own Qualia's planning and forecasting infrastructure : Lead the design, build, and continuous improvement of our operating model, annual plan, and long-range financial plan, ensuring they accurately reflect the current and future state of the business Drive financial rigor at the executive level: Lead preparation of monthly and quarterly management reporting, Board materials, and investor-facing financial packages; distill complex financial results into clear narratives that drive action at the lea
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