Kevin Huke Email & Phone Number

Malvern, PA

Regulatory submission coordinator and consultant leading eCTD publishing projects, consulting and publishing submissions for agency approval, meeting tight deadlines, and working within a team as well as individually to meet project goals.

Berwyn, PA

• Was given new title of Submission Coordinator. As a submission coordinator for eCTD submissions, has built and published IND, NDA, and Life Cycle Management submissions using eCTD tools including Viewpoint, eCTD.
• Collaborate with submission manager and regulatory affairs in planning and setting submission timelines and quality standards.
• Responsible for overall quality of deliverables through validation and compilation of submissionsto ensure all warnings and errors are reported and resolved in a timely fashion.
• Involved in the submission process by executing Initial Reviews, Publishing, and QC on all documents.
• QC each submission module completed in eCTD backbone; bookmarks and hyperlinks created and verified to ensure submission-readiness.
• Coordinate and manage project assignments, manage workflows for all publishing tasks, and communicate issues and resolutions in an appropriate time frame.

Berwyn, PA

Senior-level role, becoming trusted member of 2 teams. Played a key role on 6-member team, supporting the publishing and submission of drug studies for FDA approval.

Wayne, PA

Reviewed publishing for accuracy to ensure submission readiness. Experience publishing PDF files in all submission modules including creating bookmarks and hyperlinks, in accordance to strict regulatory compliance guidelines. Produced all submission documents in electronic format via proprietary software. Simultaneously, served on SPL (Structured Product.

West Chester, PA

• Joined control center team of home shopping channel to propel smooth operations of 4 call centers. Guided management through daily staffing changes by generating real-time historical data and workforce strategy.
• Successfully managed centers’ call volume to avoid dropped calls due to long wait times.
• Equipped management with daily reports and up-to-date communications for optimal decision making.

West Chester, PA

Provided service to customers over the phone—researching/locating products, answering inquiries, resolving problems, and recording/processing orders.