Apex Systems, Inc Monroeville , PA 15146
Quality Culture/Process Improvement Identify areas for improvement for efficiency and compliance in the internal processes, work instructions, and forms and lead Hoshin or Improvement teams to affect change. Training Maintain technical proficiency in core job functions including all applicable QSPs, WI, Forms, Philips training, and regulatory body requirements.
Acts as a Mentor/Trainer for Associate Technical Writers Regulatory and Writing Proficiency Work with assigned Regulatory Mentor(s) to maintain a working understanding of the interpretation of domestic and foreign regulations and laws as they apply to the licensing, registration, manufacture, shipping, and sale of assigned products, with a primary focus on Labeling for the mature markets: USA, Canada, EU, Japan, and Australia, and a secondary focus on Emerging Markets: Brazil, China, LATAM, AP, Russia, India.
Job Function- Work independently on assigned duties, processes and roles outlined below: 1. Sits on New Product Development Team for assigned products and provides labeling analysis on the Product Development Plan 2. Creation and execution of Labeling Plans for assigned products in the Domestic, Mature, and Emerging Markets, including released Labeling lists to support regulatory restrictions. 3.
Creation, revision, review, and approval of Labeling (User Manuals, Provider Manuals, Quick Start Guides, Product Labels, Packaging Labels, Help Files, etc.) 4. Supports Internal and External Quality Audits 5. Actively supports CAPA's as they apply to Labeling 6.
Leads Labeling Process Improvement efforts / Hoshins 7. Partners with Translation Coordinator(s) throughout the execution of the associated Labeling plans. 8. Interfaces with Business Unit functions as needed to resolve labeling concerns 9.
Tracks the impact of pending domestic and global regulatory changes on Labeling 10. Conducts department training on Labeling requirements 11. Maintains proficiency in domestic and foreign regulations and standards, with a focus on Labeling for assigned products and global impact but a regional focus on the US (FDA), EU (MDD), CA (Health Canada), BZ, JPN, and AU (TGA). Education:
B.S. or B.A in English, Writing, Life Sciences Experience: 5 7 Years of Experience. Duties and tasks reflect variety and complexity. Demonstratable excellence in command of the English Language required.
Mastery of page layout, word processing, and computer-generated illustrating using the following tools: 1. In-Design 2. Illustrator 3.
RoboHelp 4. SnagIt If interested, please send your resume to and apply online at #LI-LC1 EEO Employer Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.
Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or . VEVRAA Federal Contractor We request Priority Protected Veteran & Disabled Referrals for all of our locations within the state. We are an equal opportunity employer.
We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. The EEO is the Law poster is available here.