Our client is seeking an Associate Director of Product Labeling – Remote!
Our client is a multinational corporation that operates in many sectors of the life sciences industry. This opportunity falls within their’ pharmaceutical division, particularly within their Global Labeling Department. This position has potential for a long-term contract. The primary function of the Associate Director Product Labeling is managing document control, submissions as well as the labeling process while complying with regulatory standards in the US and EU.
- Develop target labeling and updates of product data into the system
- Facilitate labeling negotiations with both the US and EU health authorities
- Undergo the review/endorsement of labeling documents and prepare/finalize submissions according to either the US or EU regulations given the product
- Process local labeling deviation requests for the assigned product(s)
- Preparing updates to the company core data sheet and the prescribing information (US and EU) for products in additional therapeutic areas for indications, safety, and revisions
- Finalize and release the company core data sheet through review process to endorsement
- Comply with local, state, national, and international regulations throughout the process
- Minimum of a bachelor’s degree in a scientific discipline. Advanced degree (MS,Pharmd,Phd, or MD) is preferred
- Six plus years’ experience in the pharmaceutical or healthcare industry with five+ years in regulatory affairs out of the total
- Direct experience in product labeling, both prescribing and patient information
- Specific product labeling experience should include authoring text, drafting text based on scientific source data, supporting rational, regulatory requirements, standards, templates, and liaison with subject matter experts/regulatory professionals
- Advanced Microsoft Word skills, experience working in a document management system, and basic Excel/PowerPoint skills
- Excellent project management, verbal, and written communication skills