Medium size pharmaceutical company that focuses on endocrine disease and has 6 products in clinical trial and 4 products in pre-clinical phases.
What they are looking for:
- Offer worldwide expertise on electronic document management requisites, submission planning, compilation, publishing, and the administration of approval data.
- Oversee regional submissions while providing assistance for global submissions.
- Actively convey requisites and pertinent issues to the Submission Team, aiding in the realization of feasible timelines.
- Collect essential information from the Submission Team in a proactive manner.
- Conduct quality checks on documents and regulatory submissions to guarantee adherence to submission-ready benchmarks.
- Compile and disseminate regulatory submissions, adhering to prevailing standards and processes using agreed-upon tools.
- Scrutinize submissions, record life-cycle information, and maintain compliance with standards.
- Stay abreast of technical/format requirements for submissions worldwide as stipulated by regulatory authorities, ensuring their integration into RN standards
The team is about 9 people, with a Director of Strategy who has 3 reports, Associate Director of Reg Ops who has 4 reports. All of them work closely together. You would be reporting to the Manager of Reg Ops who reports to the Assocaite Director of Reg Ops.
Rate: $65-75 an hour
12 month contract.