sean culleton

Quality control and data management of Clinical Study Reports for clinicaltrials.gov using native Protocol Registration System Edited documents for regulatory submissions: CSR, protocols, Investigator’s Brochures, Informed Consent Forms, Case Report Forms, documents for Investigational Review Board Knowledge of the Title 21 Code of Federal Regulations, International Conference of Harmonization and Good Clinical Practice Guidelines Worked effectively as part of a multicultural, highly distributed, virtualized team

Technical writing and copy-editing of Usability Testing Reports for medical products Knowledge of GMP and relevant ISOs Formatted Usability Testing Reports according to FDA guidelines for “Applying Human Factors and Usability Engineering to Medical Devices to Optimize Safety and Effectiveness in Design” Worked with project manager to create in-house style guide to streamline all company documentation

Responsible for testing digital audio production equipment and software. Identified and documented hardware and software malfunctions in digital audio networks. Contributed to User Interface Design for software and hardware products.

Provided respite care to families of mentally handicapped teens and young adults diagnosed with Autism and Mental Retardation. Liaison between family and employer, to develop a trusting and communicative relationship. Observed strict rules of confidentiality. Balanced family's requests with employer's requirements and suggestions.

Coached individual mentally handicapped adults intensively on job sites. Worked with clients diagnosed with Autism and Mental Retardation. Maintained client's attitude and behavior in order to meet the needs of the employer and maintain positive contribution to the community. Mediated employer and customer interactions with client. Taught and reinforced specific job rules and procedures at specific job sites. Managed Client's paychecks and was responsible for client's work-related monetary activity.

Writes and edits regulatory documents for clients in the Pharmaceutical industry Designed and executed a digital marketing campaign, assisted with marketing strategy and logo design, writing mottos and vision statements, and editing client-facing marketing copy Supported employee recruitment Arranged meetings, recorded minutes, and tracked correspondence with stake holders

Clinical Research Assistant at The Children's Hospital of Philadelphia

Research Technician - Dr. Karen Warkentin: Adaptive Plasticity in Hatching and Metamorphosis in Red-eyed Tree Frogs (Agalychnis) - Spring 2008 - Research assistant for Dr. Walter Hopp’s book Perception and Knowledge: A Phenomenological Account (Cambridge University Press)

Study abroad 2008-2009 academic year, coursework in philosophy"]