Labeling and Technical Publications Analyst Onsite

Labeling and Technical Publications Analyst - Onsite

Pay Rate Range: $38.66/hr. - $45.33/hr.

Description/Comment:

Assists in the timely development and completion of clinical reports, summary documents, package inserts and other documents.. May oversee the electronic regulatory submission process. Oversees and provides recommendations for the development of formats and guidelines for documentation. Ensures effective planning and management of timelines for all aspects of technical documents. Creates, reviews, and releases text that meets all medical, legal, and regulatory requirements for labeling medical products. Monitors process of any changes in labeling regulations in the US and/or abroad. Reviews labeling change information, and ensures that it is supported by the data and consistent with the application.

This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires the ability to make judgements based on practice and previous experience. This job typically requires a degree or equivalent and no experience.

Additional Job Details:

The ideal candidate must have a minimum of 1 to 2 years of experience in labeling design and implementation, with a strong understanding of label design principles and layouts. Experience working with labeling software, specifically Prisym Medica 1.6 and Prisym 360, is essential, along with knowledge of the GS1-128 barcode standard and barcode grading process. The candidate should have experience in labeling and packaging design work, demonstrating the ability to maintain design aesthetics while redesigning existing layouts. Proficiency in design tools such as Adobe Illustrator and Adobe Photoshop is required, as well as strong skills in Microsoft Excel and other MS Office applications. Excellent verbal and written communication skills are essential, along with the ability to work effectively as part of a team with minimal supervision.

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county, to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.