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AGW

Clinical Labeling Operations - Remote

Career Insights for Regulatory Affairs Specialist

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What they do

A Regulatory Affairs Specialist maintains specialized knowledge of state and federal government regulations that affect an employer. Interprets regulations and implements procedures that bring an employer into compliance with regulations; may audit internal compliance with regulations.

$105,184 / year median in the U.S.

+1% projected growth

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Job Description

Aptask Global Workforce (AGW) is seeking a Graphic Designer - III for a position with a Major Pharmaceutical 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 the coordination of new clinical labeling implementation with Regulatory Affairs, Quality Assurance, and multiple packaging sites worldwide. The ideal candidate will create and review label content, manage project timelines, and ensure compliance with FDA and cGMP standards within the pharmaceutical industry.
Responsibilities:
Responsible for the coordination of new clinical labeling implementation with Regulatory Affairs Labeling, Quality Assurance Labeling, Supply Chain Labeling BPO, PM s and multiple packaging sites worldwide Creates labels content and maps content to the appropriate fields in Bartender Creates Business Continuity Labels and maps contents to the appropriate fields Reviews clinical final product label content and Bartender mapping to ensure all content matches source documents and text is mapped to the appropriate fields Liaises with Regulatory Affairs Labeling colleagues to obtain correct text, negotiate timelines and ensure that all requirements have been met Manages the completion of operational excellence projects where prior precedents may not be set and outcomes require executing without prior experience Authors standard operating procedures, guidelines and work instructions Collaborates with team members to meet departmental goals and objectives Completes 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 $56.79 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