Senior Documentation and R&D Quality Control Manager
Full-time
Remote
Summary:
The Documentation and R&D Quality Control (QC) Manager is a key highly
detailed, data-oriented interdisciplinary role within the R&D Organization, reporting to the Vice
President of Global Regulatory Affairs and supporting the regulatory, clinical, and nonclinical
functions. The person in this role is extremely organized and detail oriented. This individual
understands the need for ensuring the highest level of data reporting accuracy and consistency in
drug development documents which will ultimately be submitted to global regulators. The opportunity
is to build a strong internal quality control and document management system. This includes QC
process development, Document Management process development, Document Specialist
oversight. The role is 100% hands-on and knowledge of the electronic common technical dossier
(eCTD) format and structure is required. The Documentation and QC Manager will interact with
Research and Development personnel from the clinical and nonclinical functions at the document
and source data level to support the corporate goal of submitting accurate, high-quality validation
ready global marketing applications for approvals.
Full-time