Regulatory Labeling Specialist Jobs in California

Project Management experience, experience managing individual and group projects of moderate complexity

Experience working in a Documentum-based document management system

Provides strategic guidance on labeling regulations, requirements, competitor labeling, and labeling trends

Works with customer experience, human factors to create layouts with appropriate placement, meaning and tone

Works with customer experience, packaging engineering, branding, HF, and artwork center to create layout templates for use in HF studies

Manages the review and approval of core DHCP letters

·Manage and scope out multiple labeling projects in a highly cross-functional environment.

·Experience working independently and a track record of taking initiative

·Experience working with large data sets and keeping the quality high.

·Experience in Excel and/or SQL

·Impeccable communication and relationship-building skills

·Drive labeling workflows and projects success metrics and timeline.

Incredible company culture and proven management team

MS WORD knowledge with WORD styles to format various documents for regulatory submissions

ECTD publishing experience with using eCTD software to produce a compliant electronic submission

3+ years of Regulatory Proofreading/Publishing experience within biopharma, medical device, IVD, or CRO industries (protocols, amendments, IBs, CSRs, INDs, NDA modules)

QC experience is a plus

REMOTE | Regulatory Publishing/QC opportunity with a well-funded Rare Disease biotech

Bachelor's Degree with 1 year of related experience Required

Previous experience working in a medical/pharmaceutical FDA regulated industry

Excellent written and verbal communication skills and interpersonal relationship skills

Basic knowledge of medical device documentation development activities

Knowledge of ECR and Ignite processes

Good computer skills including usage of MS Office Suite