Vacancy expired!
CooperVision, a division of CooperCompanies (NYSE:COO), is one of the world’s leading manufacturers of soft contact lenses. The Company produces a full array of daily disposable, two-week and monthly contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism, presbyopia and childhood myopia; and offers the most complete collection of spherical, toric and multifocal products available. Through a combination of innovative products and focused practitioner support, the company brings a refreshing perspective to the marketplace, creating real advantages for customers and wearers. For more information, visitwww.coopervision.comJOB TITLE: Global Regulatory Affairs InternDEPARTMENT: RAQA
JOB SUMMARYThe CooperVision RAQA team is looking for a motivated and productive intern to work with the regulatory team to learn leadership and technical skills, and project management in a Global Regulatory environment. The Global Regulatory Affairs Intern will work directly with full-time Global Regulatory Specialists and Global Clinical Compliance Specialists with management to plan, implement and execute regulatory activities as defined. The position will entail learning the general scope of regulatory affairs and clinical compliance practices as well as managing assigned project(s) that will support the Global Regulatory Affairs group’s goals to improve efficiency, regulatory body submission intelligence, identification and implementation of clinical literature database.ESSENTIAL FUNCTIONS
Identify and implement clinical literature database.
Identify potential literature database tool. Research IT tools, capability, cost and business sense (relevancy).
Present proposal to RA management using presentation skills.
Search and appraise scientific literature.
Learn how to perform scientific literature searches to support regulatory functions. Create a focused scientific literature search based on report content/relevancy. Learn how to run report from database.
Assist with construction of regulatory internal reports such as Post-market Surveillance. Learn how to work with other team members in collaboration to provide inputs into internal regulatory reports.
Learn and conduct clinical literature appraisal that assists with Clinical Evaluation Report development. Learn clinical evaluation literature grading and appraisal skills.
Implement regulatory body submission intelligence database and process
Learn regulatory interaction with regulatory bodies with data analytics of the intelligence gathered. Learn regulatory body interactions when trying to get a product approved or cleared with a Ministry of Health.
Enter regulatory intelligence into regulatory database. Learn how to enter interactions into database. Learn how to run report from database.
Present intelligence/data. Learn how to create presentation of findings and interpretation of findings/review for any trending seen
POSITION QUALIFICATIONS/KNOWLEDGE, SKILLS AND ABILITIES/
Excellent oral and written communication skills, with ability to communicate with diverse populations.
Must be proficient with Microsoft Office including the ability to develop MS PowerPoint presentations and Excel spreadsheets (including data manipulation).
Project management, technical writing and analytical skills.
Effective communicator; able to convey messages in a logical and concise manner. Ability to read and understand highly technical material.
Understand the literature review processes and regulatory intelligence.
Works scheduled hours and is ready to work at scheduled start times. Adapts readily to changes in workload, staffing, and scheduling.
Complies with all company policies and procedures.
Complies with management direction. Seeks assistance from supervisor in identifying and reporting problems or concerns relating to job functions.
Conducts self in a professional manner with coworkers, management, customers, and others.
Models the corporate values.
/WORK ENVIRONMENT/
Typical office environment
Light lifting of documents, files, and reference books
/ //EDUCATION/
Pursuing a bachelor’s degree or master’s degree in a scientific or technical discipline from a four year college or university.
/ //EXPERIENCE/
Course related Project Management Skills
Relevant regulatory coursework
Confident in being a self-starter with the ability to work independently
Friendly and fast paced, deadline driven department
Job: Regulatory AffairsOrganization: Regulatory AffairsTitle: Global Regulatory Affairs - InternLocation: California-San RamonRequisition ID: SAN0053
Vacancy expired!