Alexa M Keenan

Keena137@umn.edu

Summary

Highly organized and detail-oriented self-starter with an ability to effectively

communicate across all organizational levels. Able to work in a fast-paced, crossfunctional environment.

Education

Work Experience

University of Minnesota, Minneapolis, MN

GPA: 3.6
Major: B.S. Scientific and Technical Communications
Minor: Public Health
Graduation Date: May 2015
Vascular Solutions Inc., Maple Grove, MN
01/2016 - Present
Marketing Clinical Technical Writer
Author Clinical Literature Reviews, Hazard Analysis Reports, and Failure
Mode Effect and Criticality Analysis Reports, and Instructions for Use
Manage quality controlled marketing documents for over 90 products
Oversee the Annual Marketing Clinical Literature Review Schedule
Provide competitive product analysis to VP of Marketing
Assist with completing and managing deadlines for all marketing
deliverables required for the Annual Risk Review Schedule
Ensure that all Class II device labels are UDI compliant with FDA
standards
Create change orders for all updated documentation in Agile
Review complaint communications, assess for regulatory compliance
and potential impact to patient safety and business operations
3M Oral Care Solutions, Maplewood, MN
Contract Customer Service Representative
Quality/ Regulatory Special Project Support
Support global medical device recall
Outbound calls to dental customers
Audit of customer data
Manage Excel spreadsheet supporting project
Issue electronic documents through PeopleSoft

07/2015 12/2015

St Jude Medical, Plymouth, MN

02/2014 - 12/2014
Strategic Marketing Analyst Intern
Develop a disease prevalence model to determine market potential
Research and analyze clinical studies and quarterly market trends
Track market, clinical, and competitive information
Update market models containing sales and market share forecasts
Monitor USA and EU regulatory approvals
Format and present data according to audience
Alexa Keenan
Keena137@umn.edu

Achievements

Coakley Ames Writing Excellence Award Recipient

University of Minnesota Deans List
Vascular Solutions Medical Device Sales Training Scholar Award

Skills

Proficient in Microsoft Office

Advanced Excel Skills (Pivot Tables, V Lookup)
Strong written and oral communication skills
Working knowledge of FDA and international regulations
Working knowledge of peripheral and coronary anatomy
Public speaking training
PeopleSoft
Siebel
Salesforce
Agile Document Management System
Project management experience

Bachelors degree or equivalent work experience, preferably in a scientific or technical discipline

3+ years of experience in the medical device industry
Able to communicate effectively across all levels of the organization
Thorough understanding of global regulations
Strong technical knowledge of medical products
Strong technical understanding of relevant procedures, practices, and associated medical terminology
Excellent research and analytical skills
Ability to manage multiple projects
Excellent written and oral communication, technical writing and editing skills
Strong leadership, interpersonal and influencing skills
Proficiency with Microsoft Office
Quality System Requirements:
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented
quality processes and procedures.
Establishes and promotes a work environment that supports the Quality Policy and Quality System.

Alexa Keenan
Keena137@umn.edu