My client is an established mid-size global biopharma company with a presence in over 30 countries that has grown their global regulatory team from seven to 21 people in the past twelve months. They are seeking a Global Labeling Expert, and in this newly created role you will be responsible for driving the creation and maintenance of the development Company Core Data Sheets.
Main Responsibilities and Accountabilities:
- Generates and maintains the development Company Core Data Sheet (dCCDS) and the Company Core Data Sheet (CCDS) as assigned by the CCDS Owner, Therapeutic Area Lead
- For the CCDS content, interacts with relevant expert departments and stakeholders, such as Global Clinical Safety and Pharmacovigilance (GCSP), Global Clinical Development (GCD), and Commercial Development and Operations (CDO).
- Ensures communication to the Regional Labeling Specialists regarding new and updated CCDSs.
- Ensures compliance between the CCDS and country/region specific labelling through deviation tracking, deviation assessment/approval, and periodic checking for compliance. Escalates deviation and compliance issues to the CCDS Owner Therapeutic Area Lead, Global Labeling Lead and/or labelling governance bodies (GLRC, LGC) as necessary.
- Supports Regional Labeling as decided by management.
- Represents Global Labeling in internal and external meetings.
- Plays an active part in projects to improve labelling
- Takes on additional tasks as decided by management.
Knowledge and Skills:
- University degree or equivalent in a scientific discipline.
- Experience in a Global Regulatory Affairs function with knowledge of regulatory product labeling and related processes.
- Excellent oral, written and interpersonal communication skills (in English)
- Attention to detail
- Organizational and project management skills
- Planning, organizing and time management skills
- Able to work across multiple disciplines and establish professional relationships
- 3-5 years of Labeling experience including development of Company Core Data Sheets