Client background
Our client is pioneering the development of a new class of therapies based on defined bacterial consortia that act by modulating the human microbiome. They have three programs in clinical trials and approximately 100 full-time employees.
Challenge
With their lead program in Phase 3 trials, our client was seeking a part-time Senior Regulatory Submissions Contractor to lead submission planning and execution for the company’s first BLA. In addition, they needed a part-time Regulatory Operations Contractor who could support eCTD publishing for a variety of submissions. Although these were both remote roles, candidates on the East Coast were preferred.
Approach
Dennis Partners recruited and vetted Regulatory Contractors who fit the client’s qualifications. We focused on senior contractors with strong submissions management experience who had previously worked on a BLA or NDA. We also looked for more junior Regulatory Operations contractors with strong eCTD publishing backgrounds. Within a week of initiating the search, Dennis Partners submitted eight resumes for the client’s review.
Result
Our client interviewed each of the candidates by video and selected their top picks for each role. Dennis Partners checked the contractors’ professional references and put together the necessary paperwork for timesheets and payroll processing. Both of these contractors have been a great fit for the organization and our client has been delighted.