A BDN client based out of Massachusetts needs an experienced regulatory project manager who can provide a minimum of six months of contract coverage. Our client needs a seasoned regulatory project manager who can help them develop and manage timelines that support regulatory approval for NDA and IND filings. On the job, the consultant will be responsible for coordinating regulatory team meetings, prepare meeting agendas, track decisions, and ultimately drive submission activities forward. Successful consultants will be able to develop an executable operational plan based on NDA development plans, mapping out future regulatory activities, and develop a master timeline for NDA submissions.
The consultant will also be expected to maintain project management information and organize all submission documentation. Candidates for this position should have experience with common project management software and tools (MS Project, MS Office, Visio, etc.) and have prior project management experience in a regulated industry.