What are the responsibilities and job description for the Regulatory Affairs Labeling Operations Fall Co-Op position at BI Pharmaceuticals, Inc.?
Boehringer Ingelheim is currently seeking a talented and innovative Intern to join our US Regulatory Affairs Labeling Operations department located at our Ridgefield facility. As an Intern, you will contribute to package labeling operational activities such as label compliance reviews and development and maintenance of packaging components).
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies´ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.
Duties & Responsibilities
- Support operational activities of labeling/packaging matters for marketed products including label compliance reviews, and development and maintenance of packaging components in line with local FDA regulations, corporate design compliance and business objectives
- Draft and review content of package labeling for management review
- Research regulations and guidance in regard to package labeling compliance to develop innovative package labeling concepts
- Evaluate innovative opportunities to improve efficiency and execution of process to support labeling initiatives in compliance with Corporate and local regulatory requirements
Requirements
- Must be a current undergraduate, graduate or advanced degree student in good academic standing.
- Student must be enrolled at a college or university for the duration of the internship.
- Overall cumulative minimum GPA from last completed quarter/semester 3.0 GPA (on a 4.0 scale) preferred.
- Major or minor in related field of internship
- Undergraduate students must have completed at least 12 credit hours at current college or university.
- Graduate and advanced degree students must have completed at least 9 credit hours at current college or university.
Desired Experience, Skills and Abilities:
- Proofreading/editing skills; excellent usage of the English language (spelling, grammar, and punctuation); the ability to work well under pressure and adapt to changing priorities.
- Proficient in MS office, with an emphasis on MS Word and PowerPoint skills
- Excellent communication (verbal, writing, and presentation) skills necessary for interacting on a daily basis to address labeling operations related matters with various personnel and line management
- Student in Pharmacy program or interest in Regulatory Affairs Labeling preferred.
Compensation
