This mid-sized, global biopharma company has multiple approved products and a strong pipeline of biotherapeutics. They are seeking a Global Labeling Contractor to handle various labeling activities for a short-term engagement. This position will be 30-40 hours a week for approximately six weeks. This is a remote/work from home position!
- Implementation of new and updated Company Core Data Sheets (CCDS’s).
- Timely provision of all required labeling documents needed by the Region for submissions to Health Authorities where product label is affected.
- Collecting, understanding, and communicating Health Authority requirements and opportunities related to product labeling for new drug applications as well as licensed products for the assigned regions.
- Interact with relevant stakeholders including the CCDS owners, regional points of contact, and local commercial organizations, as applicable.
- Ensure compliance with the regional and country-specific regulatory requirements and procedures governing leaflets and labeling. Ensure compliance of region/country specific labeling texts with the CCDS.
- Track region/country specific deviations from the CCDS and brings these deviations to the attention of the CCDS owner for decision making.
- Ensure that printed packaging materials are updated subsequent to labeling changes.
- Maintain labeling databases and systems as needed.
Knowledge and Skills:
- Bachelors degree in a scientific discipline; Advanced degree preferred.
- At least 4-5 years of regulatory experience in Labeling for pharmaceuticals or biologics.
- Experience with maintenance of Labeling texts and Company Core Data Sheets.
- Competence in documentation practices
- Planning, organizing and time management skills
- Attention to detail
- Ability to work well under pressure
- Understanding of GMP compliance, quality control procedures and documentation practices
- Excellent oral, written and interpersonal communication skills
NOTE: All candidates/contractors must be authorized to work in the United States. We cannot provide US work authorization, nor can we support corp-to-corp contractors.