Clinical Labeling Operations - Onsite

AGW - 4.3

Thousand Oaks, CA Job Details Contract Up to $54.74 an hour 7 hours ago Benefits Health insurance Dental insurance Vision insurance Paid sick time Qualifications Pharmaceutical regulatory compliance Labeling Supply chain Drug regulation GMP Pharmaceutical company experience Project task coordination Biomedical regulatory compliance Managing projects Productivity software Supply chain experience within healthcare industry FDA regulations Full Job Description Aptask Global Workforce (AGW) is seeking a Clinical Labeling Operations for an Onsite position with a Global Biotechnology Company located in Thousand Oaks, CA; El Segundo, CA; Frederick, MD; Oceanside, CA; or Foster City, CA. This is a 12+ month contract opportunity. This role is responsible for coordinating the implementation of new clinical labeling in collaboration with Regulatory Affairs, Quality Assurance, and Supply Chain teams across multiple global packaging sites. The successful candidate will create and review label content, manage project timelines, and ensure all activities adhere to FDA and cGMP standards within a regulated pharmaceutical environment.

Responsibilities:

Coordinate new clinical labeling implementation with Regulatory Affairs Labeling, Quality Assurance Labeling, Supply Chain Labeling BPO, PMs and multiple packaging sites worldwide Create label content and map content to the appropriate fields in Bartender Create Business Continuity Labels and map contents to the appropriate fields Review clinical final product label content and Bartender mapping to ensure all content matches source documents and text is mapped to the appropriate fields Liaise with Regulatory Affairs Labeling colleagues to obtain correct text, negotiate timelines and ensure that all requirements have been met Manage the completion of operational excellence projects where prior precedents may not be set and outcomes require executing without prior experience Author standard operating procedures, guidelines and work instructions Collaborate with team members to meet departmental goals and objectives Complete labeling updates as assigned

Requirements:

6+ years of relevant experience and a BS or BA or 4+ years of relevant experience and a MS Highly capable at directing and coordinating project work Strong verbal, technical writing and interpersonal skills Proficient in Microsoft Office applications Knowledge of FDA and cGMP standards as well as regulatory guidance documents Prior experience in pharmaceutical or other regulated industry is required Prior experience in clinical or commercial supply chain Familiarity with artwork/labeling production Desired skills: Familiarity with Bartender software is a bonus Pay range: up to $54.74 per hour Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position. If you have the described qualifications and are interested in this exciting opportunity, apply today! Aptask Global Workforce (AGW) ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery. Benefits of working with ApTask Global Workforce include: Medical Dental Vision Sick Pay (for applicable states/municipalities) Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website https://www.agwtalent.com/. ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran. #INDAGW