Biotechnology, Pharmaceuticals, Quality/Risk Management, US Regulatory Affairs
We have an opportunity with an International Biotech organisation for a Regulatory Affairs CMC Manager. We are looking for someone who has experienced in development and approved products. The role is full time, based primarily in Madison NJ and starting immediately.
The Manager will be responsible for supporting, strategically developing and maintaining clinical study and CMC timelines, providing evaluations of potential risks and conflicts, supporting the team on proactively resolving potential deviations, and presenting clear timeline reports. You will be working in a team-orientated environment and will be empowered to drive clinical studies and CMC activities with minimal deviations, accelerating timelines and providing metrics to implement future enhancements. Role description: * Develop and maintain high quality, realistic, cross functional clinical trial plans. The CMC Manager will develop timelines when the synopsis/draft protocol is available. * Develop and maintain high quality, realistic Chemistry, Manufacturing & Control (CMC) plans for products in development. * Partner with Project Management and Regulatory Affairs to implement project strategies and improve efficiency by identifying and implementing new business processes. * Develop and maintain NA/ROW timelines to meet all deliverables. * Partner with the Clinical Development lead, Global Operations department and the study team to ensure timely delivery of all milestones. The Manager, Clinical and CMC Planning will be expected to identify gaps and risks in the study plans and work with the team and Management to proactively develop solutions which will increase efficiency and minimize timelines. * Partner with Pharmaceutical Sciences Strategy to ensure timely delivery of all CMC milestones. The Manager, Clinical and CMC Planning will be expected to identify gaps and risks in the CMC plans and work with the team and Management to proactively develop solutions which will increase efficiency and minimize timelines. * Define baselines and provide metrics to identify areas and trends that can be used by the teams for future enhancements. * Responsible for arranging and leading discussions on the clinical study and CMC plans. * Present clear CMC plan reports to stakeholders. * Operate within the Governance Board model for communication and accountability. * Provide continuous improvement on CMC plans and standard MS Project templates. * Assist in developing the department portfolio based schedules and resource planning methodologies. * Identify state of the art planning tools to minimize deviations from established timelines.
If you would be interested in joining the team at G&L Scientific, please send your CV to talent @ gandlscientific.com today.
G&L Scientific is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race. We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process.
Internal Number: 178
About G&L Scientific Inc
G&L Scientific provides consulting, staff augmentation, outsourcing and support services for Clinical Research and Regulatory Affairs. With our own teams of experts based in our offices across Europe, Asia-Pacific and the US, as well as a pool of more than 2,500 global consultants, the key to G&L’s success is a straightforward, transparent approach; experience of unrivalled depth; and the recruitment and development of brilliant people. Indeed, the level of repeat business and ongoing long-term assignments is testament to the quality of service G&L provides.
Whether our client needs an individual RA professional or full project team, onsite or remote, G&L will design a custom solution that delivers significant savings and flexibility in line with operational demands.
As well as excellence in our chosen fields, we are renowned for the quality of our people. Our real success lies in recruiting and developing brilliant consultants. We seek the right individuals to match our business needs, then build the environment that allows them to fulfill their potential. People join G&L Scientific for a variety of reasons. Some want to work with the very latest developments in Clinical Res...earch & Regulatory Affairs, others want the opportunity to make a real difference working in a dynamic and pioneering team. Ultimately, G&L people are free-thinking, proactive and creative individuals who are not afraid of change.