The Regulatory Operations and Submissions Manager manages complex submission projects and related processes. Working... cross-functionally to maintain processes and procedures related to regulatory submissions, the individual will assist in...
s clinical development programs. Reporting directly to the Chief Medical Officer (CMO), the Senior Director/ VP of Clinical.... Trial Design and Execution: Work with Chief Medical Officer to design Clinical Programs. Oversee the implementation...
The Medical Adviser represents the local organizations medical/scientific voice of expertise for assigned product.../scientific meetings, and provides medical affairs support to cross-functional teams. She/He ensures that the medical affairs role...
and ICH/GCP requirements. Establishes collaborative working relationships with internal members of the Clinical Development group... reports to the Director of Clinical Operations and is an individual contributor to the successful achievement of the Clinical...
and contribute to the implementation of best practices within the Quality department. Ensure laboratory instruments are calibrated... and external audits as needed. Perform Environmental Services sampling and monitoring as required. Collaborate with the Process...
The CMC Project Manager will support GMP manufacturing of AAV gene therapy at contract development and manufacturing... organizations (CDMO), oversee contract testing labs, and help support the GMP batch record review process. This position...
for one pipeline product. Reporting to the Vice President, Sales and Marketing, the person in this role will develop and manage brand... and launch plans for the brand in the US market, collaborate with cross-functional stakeholders to develop and successfully...
Our client is developing first-in-class therapies designed to reprogram the immune system to achieve antigen-specific... tolerance for immune-mediated disease. They are seeking a Quality Leader to grow the capability of the quality assurance...
autologous and allogenic cell therapies, viral vectors, mRNA, and other modalities. The Head of Manufacturing will be responsible... for leading and managing daily manufacturing activities to ensure safe and timely delivery for internal and client programs. The...
Our client is looking to add a Marketing Manager to their team on a direct-hire basis. Reporting to the General Manager..., this is a new role, due to growth, and will be responsible for developing and executing a brand strategy for one pharma product. The...