Freelance Clinical Program Manager

EPM are currently supporting a West Coast Biotech in the recruitment of a Freelance Clinical Program Manager. This biotech is in the immunology space. Please see more information about the role and contract below.

• Start Date - ASAP
• Contract Length - 6 Months (potential to extend)
• Location - Remite (periodic days in office, must be in Pacific Timezone)
• Preferences - Experience working in the immunology space and small biotechs.

Responsibilities:

• Act as liaison between Regulatory and other Development functions; gathering and disseminating key decisions and updates across cross-functional workstreams and activities.
• Providing Regulatory Submission Program Management support including timeline development, issue and risk management, status reporting and meeting facilitation both generally and for specific modules.
• Work with other program managers to integrate module timelines and deliverables into the overall Regulatory Submission plans.
• Collaborate with Regulatory and cross functional stakeholders to manage timeline for submission documents, including IB, DSUR, PSUR, ODD annual updates, and annual reports.
• Support development and maintenance of the Smartsheet environment necessary to manage Regulatory filings, including creating/maintaining templates and dashboards, setting up automation and transferring existing plans.
• Provide program management support for briefing documents and agency meetings.

If this is a role you would be interested in, please apply and feel free to share amongst your network.