1 jobs found in short hills

RESPONSIBILITIES • Utilize regulatory, labeling and project management expertise to oversee and support the development, review and delivery of CDS, CSI, USPI, SPC (for products registered in the EU via the Centralized, Mutual Recognition or Decentralized procedures) and their associated Patient Labeling Documents. • Engage in and contribute to Labeling Team discussions around content and format of the above mentioned documents, as well as downstream impact on LPDs worldwide. • Act as a reviewer and signatory during review of labeling ensuring that content complies with regulatory requirements and guidelines and company policies and procedures and that the label content can be transcribed into the LPDs worldwide. • Prioritize Labeling Team activities and set clear targets using project management tools. Follow up with Labeling Team members to secure their contributions so that internal and external deadlines are met. Identify and assist teams to overcome barriers in achieving...