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Clinical Development & Regulatory Affairs Intern

900741
Labrys Biologics
Clinical Development & Regulatory Affairs Intern

- Pursuing a Bachelor, Master, or PhD degree in science or related field.

- Applicants must be currently enrolled in an academic program.

- Excellent verbal and written communication skills

- Organizational skills

- Demonstrated experience participating and/or leading projects in either an academic or work environment

- Strong computer skills with emphasis on presentations (Excel, PowerPoint, etc)

- Ability to effectively and efficiently manage schedule to accomplish assignments

- Strong sense of integrity and work ethic
7/26/2013 7:40:49 AM
San Mateo, Northern CA,CA,US

Labrys Biologics is a private, venture-financed development stage biotechnology company located in San Mateo, CA focused on treatments for chronic migraine. The company is currently seeking an intern to work with its clinical development functional team leaders to support the launch of Labrys’ early stage clinical trials. In this role, the candidate will gain exposure to regulatory, quality, clinical operations and drug manufacturing ramp up efforts for Labrys’ lead candidate, LBR-101, which is an anti-CGRP monoclonal antibody for the treatment of chronic migraine slated to enter Phase 2 clinical trials in 2013.

Position Duties:

• Assist with setting up logistics for projects related to clinical, regulatory and non-clinical activities.
• The candidate/intern may be authorized, under supervision, to provide communications to outside vendors related to projects noted above (except to regulatory agencies)
• May review and analyze documents and data for consistency, coherence and adherence to regulatory standards
• Assist in setting up design tools and presentations using various MS office applications (Word, Excel, Powerpoint, Project)
• Assist in reviewing, tracking and analyzing adherence of vendors to contracted activities and milestones

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