Life Sciences & Technology
| Clinical Research & Clinical Affairs
Location: Company is based in New Jersey but assignment will be remote
Duration: 3 Months
A Black Diamond client is looking for a CMC Consultant who is experienced in leading and performing detailed risk assessments focused on CMC. This is part of the company’s several Global Oneness Projects in CMC and is a critical initiative.
The consultant would need to lead various CMC teams (small molecule group, biologics team, etc.) through the exercise, develop the necessary processes, training, procedures, etc. improve on/develop existing internal risk management/assessment guidance documents and help develop the risk based strategy and apply the methodologies to CMC department. The goal would be to apply risk assessment to focus on the risks most likely to be problematic, allowing for appropriate resource allocation, streamlined development process and seamless due diligence.
The consultant would need to have significant performing/applying risk assessment, risk management, have strong CMC background/experience and be able to lead teams and drive the project through to completion.