Offer type: full time
Location: New Jersey - Bridgewater
The Senior Manager, Labeling will prepare corporate, US and EU labeling (prescribing information and patient information) documents for developmental, mature and marketed central nervous system and anti-infective products to obtain company and/or agency approval.
Development of labeling for these products is based on study results, coordination of labeling review and approval throughout the company, preparation of labeling components for submission to regulatory agencies, and participation in labeling negotiations with agencies resulting in product approvals or labeling updates.
The position also includes review of local labeling to assure compliance with corporate labeling. Prepares labeling that supports the safe and effective use of the product that meets the company's strategc requirements. Challenges encountered are to enable representatives from all of the major disciplines involved (preclinical, clinical, CMC, regulatory, and legal) to reach agreement on the best competitive labeling for the product.
This position requires decisions regarding best approach to labeling text, i.e., what is the best way to clearly and concisely present the labeling text in an unambiguous manner; and decisions that the text is complete and exactly as approved either internally or by a regulatory agency. The main impact would be the cost if a significant error occurred in the final labeling preparation that resulted in a product recall due to labeling.
Knowledge of regulatory requirements pertaining to marketing authorization filings for new products or updates to existing products; knowledge of labeling requirements; organizational skills and strong ability to network and coordinate discussions across all levels of the company to reach resolution on labeling topics.
A Master's degree in scientific or medically-related field. Minimum of five years experience in the pharmaceutical industry and eight or more years in work experience.