Jim Kiely

About Jim Kiely

I am a director within the life-science industry whose management style emphasizes knowledge, research, long-term thinking and respect among peers. Technological advances coupled with emerging FDA and EMA guidances and regulations are moving life-science companies toward integration of cross-departmental data and document systems that typically are now siloed and incompatible with one another. While these changes are challenging, in the end they will introduce new levels of efficiency to host companies and greater product transparency to regulatory authorities. My abilities as a director have led companies toward attaining this integration goal.Within the industry, I have written submissions for product and site approvals in the US, Canada, South America and the Baltics. On the technical side, I have created and integrated electronic data and document systems, written SOPs, RFPs and test scripts for new technologies and served as the intermediary between IT experts and end users within regulatory and clinical environments. During a 2017 buyout, I was responsible for directing the validation and transfer of all regulatory intellectual property to the buying company. I can be reached at j••••••••@gmail.comSpecialties: Writing, facilitation and consensus building, budget and personnel management, project and program management, process and policy development, regulatory oversight

Experience

1. Co-owner with Marc Gurton

   13forest Gallery

   Jan 2005 — Present · Arlington, MA, US

   13FOREST Gallery is located at 167A Massachusetts Avenue in Arlington. It provides local painters, printmakers and artisans with a venue in which their work can be sold, which makes it unique in the Boston area. Exhibitions are launched ever 6-8 weeks.

Education

• Harvard Landscape Institute

  Landscape Design

  2004 — 2007