Toronto, Ontario, Canada
As a certified Prince2 Project Manager, I’ve led complex, cross-functional projects within regulated industries like pharmaceuticals and lifesciences. I specialize in managing full project lifecycles, with extensive experience in system delivery projects—including systems, data, processes, and people. I excel at balancing scope, schedule, risk, and stakeholder alignment across global teams, leveraging tools like Jira, Smartsheet, Microsoft Project, Confluence and Miro to ensure project success. Experienced in leading cross-functional teams and managing vendor, consultant, and strategic partner relationships to deliver projects on time and with high quality. Adept at ensuring regulatory compliance, identifying opportunities for process improvement, and driving innovation through strategic recommendations. Professional & Leadership Skills • Regulatory Technology Leadership – Led million-dollar programs in regulated industries, ensuring compliance with pharmaceutical and medical affairs processes. • Cross-Functional Team Leadership – Managed distributed teams across IT, business, and vendor organizations to deliver on time, on scope, and on budget. • Stakeholder & Vendor Management – Liaised between Business System Owners, Product Owners, and Technology Owners to align technical solutions with business needs. • Strategic Planning & Execution – Developed and executed project charters, RAID logs, and roadmaps, balancing scope, schedule, risk, and quality. • Process Improvement & Automation – Designed AI/ML-driven solutions that reduced manual workload by 65%+ through automation of regulatory structured/unstructured document processing and Gen AI document intelligence. • Performance & Quality Assurance – Oversaw performance testing, validation, and IT security assessments, ensuring system reliability and regulatory compliance. • Change & Risk Management – Implemented IT Change Controls, coordinated regulatory risk assessments, and maintained business continuity. • Training & Knowledge Transfer – Designed and delivered technical training, workshops, and documentation to ensure smooth adoption of new systems and processes.
𝗨𝗽𝘀𝗸𝗶𝗹𝗹𝗲𝗱 𝗶𝗻 𝗔𝗜/𝗠𝗮𝗰𝗵𝗶𝗻𝗲 𝗟𝗲𝗮𝗿𝗻𝗶𝗻𝗴: 𝗔𝗴𝗲𝗻𝘁𝗶𝗰 𝗔𝗜 𝗖𝗲𝗿𝘁𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 | 𝗜𝗕𝗠 𝗞𝗲𝘆 𝗛𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁𝘀: 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁 𝗖𝗵𝗮𝘁 𝘃𝗶𝗮 𝗔𝗴𝗲𝗻𝘁𝗶𝗰 𝗥𝗔𝗚: Developed multi-agent systems for document analysis, reducing AI hallucinations and ensuring source-backed answers. 𝗔𝗜 𝗪𝗼𝗿𝗸𝗳𝗹𝗼𝘄𝘀: Created agents for nutrition coaching and content generation using Gradio and LangChain. 𝗥𝗲𝗮𝗰𝘁 𝗙𝗿𝗮𝗺𝗲𝘄𝗼𝗿𝗸: Built agents for dynamic problem-solving. 𝗛𝗲𝗮𝗹𝘁𝗵𝗰𝗮𝗿𝗲 & 𝗖𝘂𝘀𝘁𝗼𝗺𝗲𝗿 𝗦𝘂𝗽𝗽𝗼𝗿𝘁: Designed agents for medical recommendations and customer service automation, improving workflow efficiency. 𝗟𝗟𝗠𝘀 𝗖𝗲𝗿𝘁𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 | 𝗨𝗻𝗶𝘃𝗲𝗿𝘀𝗶𝘁𝘆 𝗼𝗳 𝗪𝗮𝘁𝗲𝗿𝗹𝗼𝗼 𝗞𝗲𝘆 𝗛𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁𝘀: 𝗟𝗟𝗠 𝗙𝗶𝗻𝗲-𝘁𝘂𝗻𝗶𝗻𝗴: Fine-tuned GPT-3.5 and Mistral-7B for classification and multi-document Q&A. 𝗡𝗟𝗣 𝗔𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻𝘀: Built agents using LangChain for RAG and optimized text workflows. 𝗔𝗱𝘃𝗮𝗻𝗰𝗲𝗱 𝗜𝗻𝗳𝗲𝗿𝗲𝗻𝗰𝗲: Applied zero-shot and few-shot techniques for real-time tasks. 𝗦𝘂𝗽𝗲𝗿𝘃𝗶𝘀𝗲𝗱 𝗠𝗟 𝗖𝗲𝗿𝘁𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 | 𝗨𝗻𝗶𝘃𝗲𝗿𝘀𝗶𝘁𝘆 𝗼𝗳 𝗪𝗮𝘁𝗲𝗿𝗹𝗼𝗼 𝗞𝗲𝘆 𝗛𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁𝘀: 𝗥𝗲𝗴𝗿𝗲𝘀𝘀𝗶𝗼𝗻 & 𝗖𝗹𝗮𝘀𝘀𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻: Built models using Linear Regression, Logistic Regression, and KNN, with cross-validation and hyperparameter tuning. 𝗘𝗻𝘀𝗲𝗺𝗯𝗹𝗲 𝗠𝗲𝘁𝗵𝗼𝗱𝘀: Developed Random Forest and Gradient Boosting models. 𝗠𝗼𝗱𝗲𝗹 𝗘𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝗼𝗻: Used metrics like confusion matrix, ROC-AUC, and F1-score for performance assessment. 𝗣𝘆𝘁𝗵𝗼𝗻 𝗳𝗼𝗿 𝗠𝗟 𝗖𝗲𝗿𝘁𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 | 𝗨𝗻𝗶𝘃𝗲𝗿𝘀𝗶𝘁𝘆 𝗼𝗳 𝗪𝗮𝘁𝗲𝗿𝗹𝗼𝗼 𝗞𝗲𝘆 𝗛𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁𝘀: 𝗗𝗮𝘁𝗮 𝗣𝗿𝗲𝗽: Handled missing values, encoding, and feature scaling. 𝗠𝗼𝗱𝗲𝗹𝗶𝗻𝗴: Developed regression and classification models, optimizing for accuracy, precision, and recall. 𝗩𝗶𝘀𝘂𝗮𝗹𝗶𝘇𝗮𝘁𝗶𝗼𝗻: Proficient in Pandas, Matplotlib, and Seaborn for data analysis.
ICON is a world-leading CRO powered by healthcare intelligence. I've served as a Consultant at Takeda through ICON Plc. 𝗞𝗲𝘆 𝗖𝗼𝗻𝘁𝗿𝗶𝗯𝘂𝘁𝗶𝗼𝗻𝘀: 𝗗𝗮𝘁𝗮 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁/𝗚𝗼𝘃𝗲𝗿𝗻𝗮𝗻𝗰𝗲 • Led the charge in ensuring data governance met all regulatory standards (GxP, FDA CFR 21 Part 11, Annex 11), keeping data accurate, secure, and easily accessible. • Focused on maintaining data quality through continuous monitoring and by applying FAIR principles and ALCOA+, driving strong compliance across the board. • Onboarded new markets into the Global Vault, simplifying the migration of legacy data and working closely with cross-functional teams to support data stewardship goals. 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗧𝗲𝗰𝗵𝗻𝗼𝗹𝗼𝗴𝘆/𝗣𝗿𝗼𝗷𝗲𝗰𝘁 𝗺𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 • Managed all aspects of regulatory technology projects, from scope and timelines to risk management, making sure everything stayed on track and aligned with compliance standards. • Led the GEN AI Document Intelligence RAG program, which helped clinical teams work more efficiently with data, cutting down on manual processes. • Created and maintained clear project documentation, ensuring open communication with stakeholders to keep everything running smoothly from start to finish. 𝗖𝗹𝗶𝗲𝗻𝘁/𝗦𝘁𝗮𝗸𝗲𝗵𝗼𝗹𝗱𝗲𝗿 𝗘𝗻𝗴𝗮𝗴𝗲𝗺𝗲𝗻𝘁 • Built strong relationships with clients by understanding their data needs and providing solutions that aligned with their business goals. • Delivered engaging presentations and training (xAPI/SCORM compliant), ensuring clients felt supported and confident in using the solutions. • Worked closely with cross-functional teams to continuously improve data solutions and enhance the client experience, resulting in more streamlined and effective outcomes.
ICON – World-Leading CRO Powered by Healthcare Intelligence Consultant at Takeda through ICON Plc 𝗞𝗲𝘆 𝗖𝗼𝗻𝘁𝗿𝗶𝗯𝘂𝘁𝗶𝗼𝗻𝘀: 𝗚𝗹𝗼𝗯𝗮𝗹 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗢𝗽𝗲𝗿𝗮𝘁𝗶𝗼𝗻𝘀 & 𝗦𝘆𝘀𝘁𝗲𝗺𝘀: • Senior Regulatory Systems Specialist at Takeda, overseeing submissions, publishing, and archival. • Provided business analysis for Global Regulatory Affairs, driving continuous improvement and ensuring seamless system functionality. 𝗣𝗿𝗼𝗷𝗲𝗰𝘁 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 – 𝗣𝗿𝗼𝗱𝘂𝗰𝘁 𝗗𝗶𝘃𝗲𝘀𝘁𝗺𝗲𝗻𝘁 & 𝗗𝗮𝘁𝗮 𝗠𝗶𝗴𝗿𝗮𝘁𝗶𝗼𝗻: • Led and managed complex product divestment projects, ensuring regulatory compliance throughout the process. Identified and facilitated the opportunity to host some divested products on ICON’s Vault, enabling buyers without systems to maintain seamless regulatory compliance and avoid operational disruptions. • Led a distributed team of 8, managing the data enrichment project required for the migration of a legacy submission archival system to a SaaS-based platform, enhancing accessibility, streamlining workflows, and ensuring robust compliance tracking. 𝗣𝗿𝗼𝗰𝗲𝘀𝘀 𝗜𝗺𝗽𝗿𝗼𝘃𝗲𝗺𝗲𝗻𝘁 & 𝗔𝘂𝘁𝗼𝗺𝗮𝘁𝗶𝗼𝗻 𝗟𝗲𝗮𝗱𝗲𝗿𝘀𝗵𝗶𝗽: • Automation Strategy Lead: Championed Automation solutions to optimize regulatory workflows, reducing manual effort, improving efficiency, and minimizing human error. • Spearheaded the automation of a process previously requiring 6 team members over 6 months. Using Python, Apache Tika, and Tesseract, I extracted data from 450,000+ unstructured regulatory documents, reducing effort and timelines by 65%. • Streamlined product divestment processes by automating key steps, reducing errors, ensuring compliance, and accelerating task completion.
• Provided Subject Matter Expertise and Consulting for Documentum-based Life Sciences solutions, assisting top pharmaceutical companies across multiple geographies (GEOs). • Specialized in upgrading and migrating legacy on-prem content management systems, improving operational efficiency and enabling cloud modernization. • Collaborated with customer architects to migrate content management platforms to public clouds (Azure, AWS, GCP), enhancing system reliability and accessibility. • Led transitions from legacy systems to containerized solutions on Kubernetes (AKS, EKS, GKE), enabling cloud-native, scalable deployments. • Designed custom Helm charts for ECM and archival solutions, streamlining deployments and standardizing configurations. • Supported internal teams, Product manager and pre-sales in containerizing legacy applications for demos and testing, optimizing scalability, maintainability, and performance.