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Senior Documentation and R&D Quality Control Manager




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.