Grant Griffin's Email Addresses & Phone Numbers

Building a career in global regulatory affairs strategy, regulatory intelligence, and clinical trials data disclosure strategy through education, experience, research, and networking. An emerging leader with certified knowledge of FDA and ICH regulations and guidelines with both pharmaceutical regulatory and medical device clinical experience. Strong background in clinical trial management and hands-on patient care. A developing public...

Building a career in global regulatory affairs strategy, regulatory intelligence, and clinical trials data disclosure strategy through education, experience, research, and networking. An emerging leader with certified knowledge of FDA and ICH regulations and guidelines with both pharmaceutical regulatory and medical device clinical experience. Strong background in clinical trial management and hands-on patient care. A developing public speaker with exceptional analytical skills, attention to detail, and writing aptitude.Regulatory Affairs Manager, US and Canada Area and Affiliate Strategy, Antiviral TA @ From September 2015 to Present (4 months) Regulatory Affairs Contractor, US and Canada Area and Affiliate Strategy, Oncology TA @ From August 2015 to September 2015 (2 months) Regulatory Affairs Contractor, Submission Operations @  Responsible for authoring or drafting cover letters and planning, publishing, QC’ing, reviewing, and/or archiving daily IND and/or NDA electronic Common Technical Document (eCTD) submissions, including protocol amendments, information amendments, general correspondence, safety reports, annual reports, CMC post approval change supplements, SPL, and other submissions. Allow regulatory affairs strategy leads to redirect at least four hours/week to more core strategic pursuits.  Forge excellent working relationships with RA leads and management, resulting in increased visibility and participation in strategic decision.  Ensure compliance by partnering with management to update templates, standard operating procedures (SOPs), and job aid documents. Present to all Submission Operations staff and train colleagues to draft FDA cover letters, Form FDA 1571s, Form FDA 3674s, and Form 356hs. From January 2013 to August 2015 (2 years 8 months) Regulatory Affairs Contractor @  Responsible for planning, creating, and reviewing critical IND submission documents including safety reports, information amendments, protocol amendments, and general correspondence, thereby allowing RA leads to redirect at least four hours/week to more strategic pursuits.  Forged excellent working relationships with RA leads and management, resulting in increased visibility and participation in strategic decision.  Ensured compliance by partnering with management to update templates, standard operating procedures (SOP) and job aid documents.  Developed monthly metrics gathering processes to aid in strategic planning activities.  Devised and implemented a process to simultaneously submit dozens of safety reports that were received as a batch due to a compliance failure at a third party clinical site. From August 2010 to December 2012 (2 years 5 months) Clinical Research Coordinator @  Key member of a busy research-based group practice responsible for all aspects of clinical trial management related to Investigational Device Exemptions (IDEs), Humanitarian Device Exemptions (HDEs), Premarket Approvals (PMAs), and Premarket Notifications 510(k).  Obtained Institutional Review Board (IRB) approval, maintained contract and billing documentation and device accountability logs, conducted NIH Stroke Scale (NIHSS) and Modified Rankin Scale (mRS) assessments, and reported adverse events.  Ensured compliance by by coordinating site initiation and monitoring by sponsors or Contract Research Organizations (CROs) and preparing for FDA audits.  Utilized technical writing skills to draft study protocols, informed consents, and source document worksheets for Case Report Forms (CRFs). From July 2007 to July 2010 (3 years 1 month) Patient Care Technician @  Provided top quality patient care, including wound care, respiratory therapy, feeding tube setup, ostomy care, catheterization, specimen collection, point-of-care blood glucose testing, and quality control.  Improved compliance by performing electronic medical record review to assist in the evaluation of staff adherence to care protocols. From May 2006 to June 2007 (1 year 2 months) Doctor of Regulatory Science (DRSc), Regulatory Science @ University of Southern California From 2012 to 2016 Master of Science (M.S.), Regulatory Science @ University of Southern California From 2011 to 2013 Non-Degree, Pre-Health @ Northwestern University From 2007 to 2009 Non-Degree, Clinical Research @ Northwestern University From 2007 to 2007 Bachelor of Arts, Russian, History @ University of Iowa From 2001 to 2005 Grant Griffin is skilled in: FDA, Lifesciences, Regulatory Affairs, CRO, Clinical Trials, CTMS, Software Documentation, Clinical Research, Medical Devices, Protocol, eCTD, Regulatory Requirements, Pharmaceutical Industry, Regulatory Submissions, Life Sciences, GMP, SOP, Drug Development