- Title: Labeling Associate
- Code: RCI-9844700
- Location: Princeton New Jersey (NJ) 08540
- Posted Date: 02/04/2020
- Duration: 10 Months
Talk to our Recruiter
- Name:Vishal Trivedi
- Email: email@example.com
- Phone: 908-704-8843 ✖ 435
- Prepare, review, approve and manage labeling for pharmaceutical products for FDA submission in accordance with FDA regulations
- Responsible for the creation of pharmaceutical labeling drafts for submission to FDA based on Reference Listed Drug labeling, FDA requirements and company’s requirements.
- Responsible for the creation of labeling in SPL and PLR format.
- Responsible for working with outside vendors for creation of labeling proofs and ensuring accuracy of final labeling.
- Responsible for managing and tracking the review process for labeling pieces to ensure timely submissions to FDA.
- Responsible for identifying changes needed for FDA approved labeling including updates to Reference Listed Drug, USP updates and updates for new Regulatory requirements.
- Responsible for maintenance of all labeling files in accordance with internal procedures
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
- The requirements listed below are representative of the knowledge, skill, and /or ability required.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
- Ability to work under tight deadline pressure and handle multiple projects.
- Must have ability to take and follow directions.
- Familiarity with FDA Labeling guidelines (21 CFR) required.
- Must possess excellent communication and organizational skills, be a team player and have a meticulous eye for details.
- 5-8 Years Pharmaceutical Labeling Experience
- SPL, Word, Excel, PowerPoint
- Minimum BA degree