The Clinical Supply Specialist will be responsible for operations support for an assigned portfolio of clinical materials. They will interface between the clinical planning organization, Global Supply Execution Teams, material suppliers, packaging operators, and the label print room. They will be responsible for ensuring a seamless transformation of a supply forecast into an executable schedule for their assigned clinical studies. Primary responsibilities will be in the areas of label development, materials planning, production data management, and production scheduling. Depending upon experience and training interest/aptitude, the successful candidate may have a primary subject matter expertise within these fields while at the same time maintaining a minimum competency in all areas.
- Create and revise labeling artwork for medical products and ensure label contents meet all medical, legal and regulatory requirements.
- Monitor order status and availability, production schedules and project timelines.
- Proofread labeling artwork and incoming vendor proofs.
- Represent label development in Global Supply Execution Team (GSET) meetings and production meetings.
- Collaborate with various internal functional group members and external suppliers to provide labeling solutions in support of domestic and ex-US clinical trials.
- Communicate timelines and provide project updates to customers and business partners.
- Facilitate issue resolution by providing input and coordinating with the label print room and other key stakeholders.
- Monitor changes in labeling regulations from domestic and global agencies, including fulfilling the role of Local Label Representative (LLR) for the US as well as liaising with Local Label Representatives (LLRs) in Roche's affiliate organizations on global translations.
- Evaluate, recommend, and implement improvements to the labeling process, quality, systems and policies.