Katherine Hardwick Email & Phone Number

Boston, MA

• Lead multifaceted project plans from project initiation to close out
• Develops and manages regulatory submissions and Agency interactions, from early to late phase programs in gene therapy and small molecule products, utilizing FDA, EMA, and country specific guidance
• Lead complex transitional plan to transfer sponsor of an active product
• Facilitates the definition of the project milestones, tasks, deliverables, key dependencies and resource requirements
• Coordinates timelines, preparation, and logistics for FDA Agency Meetings
• Generates and maintains status reports and other project related artifacts

Boston, MA

• Continued responsibilities of Administrative Associate II role
• Helped maintain project dashboards for Submission Management Team
• Worked with Regulatory Compliance & Process Management to provide consistent training curricula within Global Regulatory Affairs
• Developed and maintained SharePoint sites for Global Regulatory Affairs
• Provided administrative support for a drug product team
• Assisted VP of Regulatory Policy & Operations with the management of departmental initiatives and projects

Boston, MA

• Supported the Global Regulatory Affairs Vice President of Regulatory Policy & Operations
• Arranged functional area meetings, provided agendas, and documented minutes
• Provided logistical planning and administrative support (e.g. travel, expenses, scheduling, catering) for Regulatory Policy & Operations team
• Ensured all departmental needs were met; such as, ordering office supplies, addressing concerns, and providing backup for other administrative associates

Boston, MA

Braintree, MA

• Identified potential students who would be good candidates for enrollment in University
• Established relationships with students to ensure education and career goals aligned
• Built pipeline of potential students to guarantee campus programs started with average of 10 students
• Worked with departments to build successful class sequence to maintain student success and retention
• Garnered enough student interest in the MBA program to offer it on the campus
• Developed outreach strategy to recapture students out of attendance 365+ days which led to an increase of 2 students returning per month

Braintree, MA

• Collaborated with C-Level to develop a role for the University that would drive outcomes and increase revenue
• Developed a new student retention strategy to support students through their initial classes
• Built relationships and trust with students for them to feel comfortable discussing any issues
• Formed connections between different departments to ensure student success
• Created all documentation needed within role
• Saw 20% increase in first course completion at campus

Lenexa, KS

• Worked with team and C-Level to create outreach strategy to recapture students out of attendance 365+ days
• Created spreadsheet utilized to track student enrollment progression from initial interest through 1st class
• Identified and counseled potential students interested in returning
• Developed a pipeline of interested students to maintain an average of 12 student starts per month
• Assisted students with any paperwork or appeals needed
• Collaborated with different departments to ensure student transition back into classes were seamless

Kansas City, Missouri Area