Experience

TREND Community

• United States
• Biotechnology
• 1 - 100 Employee

• Co-Founder/CEO

  • Jun 2017 - 6 years 7 months

  Greater Philadelphia Area



CDISC

• United States
• Non-profit Organizations
• 1 - 100 Employee

• CDISC Blue Ribbon Commissioner

  • Mar 2018 - 5 years 10 months

• Commissioner on the CDISC Blue Ribbon Commission

  • Jan 2018 - 6 years


MassChallenge
• United States
• Venture Capital and Private Equity Principals
• 1 - 100 Employee
• Finalist

  • Jun 2018 - 5 years 7 months

WMackin & Associates Inc
• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee
• Head of Project Management

  • Jan 2008 - 16 years


Formed, Inc.

• United States
• Retail

• Founder/Partner

  • 2007 - 16 years

  Philadelphia, PA Founded in 2007, Formed builds health-focused data solutions. The Company helps communities and organizations capture, manage and share information. Designed and deployed in accordance with FDA guidelines on electronic records and electronic signatures (21-CFR part 11), our applications are HIPAA compliant. Formed is currently conducting a private beta for TREND, its community empowerment platform designed to: track diet and other health data, compare outcomes and milestones with peers… Show more Founded in 2007, Formed builds health-focused data solutions. The Company helps communities and organizations capture, manage and share information. Designed and deployed in accordance with FDA guidelines on electronic records and electronic signatures (21-CFR part 11), our applications are HIPAA compliant. Formed is currently conducting a private beta for TREND, its community empowerment platform designed to: track diet and other health data, compare outcomes and milestones with peers, generate health trajectories, and test hypotheses using crowdsourced data (trend.community). Show less



Consultant

• United States
• Advertising Services

• Compliance Project Manager with a focus on technology

  • 2000 - 23 years

  I manage project, operational, and strategic ventures in the biotech and pharmaceutical industries. I have extensive experience working with the follwing Enterprise database and document management software: * Oracle; * SQL Server; * Sharepoint; and * Documentum. I am well-versed in the following technical guidelines: * electronic submission of regulatory documents (eCTD); and * FDA guidelines on electronic records and electronic signatures (21-CFR part… Show more I manage project, operational, and strategic ventures in the biotech and pharmaceutical industries. I have extensive experience working with the follwing Enterprise database and document management software: * Oracle; * SQL Server; * Sharepoint; and * Documentum. I am well-versed in the following technical guidelines: * electronic submission of regulatory documents (eCTD); and * FDA guidelines on electronic records and electronic signatures (21-CFR part 11); I hold the following certifications: * Division of AIDS (DAIDS) Human Subjects Protection (HSP) and Good Clinical Practice (GCP), and FDA Regulations Comprehensive Training Workshop; and * Human Research Curriculum: Belmont Report and CITI Course Introduction, History and Ethical Priciples, Basic Instituational Review Board (IRB) Regulations and Review Process, Informed Consent, HIPAA and Human Subjects Research. My specific services include: * document preparation and process management for the electronic submission of regulatory documents (eCTD); * system design, audit and validation in accordance with FDA guidelines on electronic records and electronic signatures (21-CFR part 11); and * development of organization policy and standard operating procedures. Show less