B. Braun Medical Inc.Requisition ID
B. Braun Medical Inc# of Openings
8am to 5pmSite
With a nationwide sales team and several manufacturing locations, B. Braun Medical has become a leading full-line supplier of healthcare products and services in the U.S. The company is committed to delivering innovative products and services with unmatched quality, superior technology, and cost-effectiveness, while maintaining environmental responsibility. Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. B. Braun employs over 4,500 people in the USA. B. Braun Medical Inc. began its operations in the USA in 1957. Initially, the company manufactured and sold disposable plastic syringes. During the 1980s and early 1990s, the company undertook several expansions and enlarged its product line of disposable medical devices. With the acquisition of McGaw, Inc. in 1997, including Central Admixture Pharmacy Services, Inc. (CAPS®), B. Braun dramatically broadened its product lines and services to U.S. customers.
U.S. Facilities and Operations:
Supporting product sales are a network of nationwide marketing and manufacturing locations. Bethlehem, Pennsylvania, is home to the U.S. Corporate Headquarters along with the marketing offices of the Hospital, Outpatient Markets (OPM), Renal Therapies, Vascular Interventional, International, and OEM Divisions. Central Admixture Pharmacy Services, Inc.(CAPS®) is also managed from this location. The nearby Allentown, Pennsylvania, facility manufactures Needle-free products, IV Safety Catheters, Anesthesia Systems, Introducers, Pharmacy Admixture products. Vascular products including Right Heart Catheters and Interventional Accessories are also manufactured in Allentown. The Irvine, California facility produces IV Solutions, Basic and Specialty Nutrition, Drug Delivery, and BTC products. Infusion Pump Systems are manufactured in Carrollton, Texas and IV administration and IV and Irrigation sets are produced in the Dominican Republic.Responsibilities: Position Summary:
Coordinate labeling projects for pharmaceutical or device with minimal supervision. Prepare labels and related support documentation for regulatory submissions. Create, obtain approval, and ensure implementation of new and revised labeling in accordance with applicable regulations and policies. Coordinate with outside vendors and manufacturing to ensure ordering, receipt, and implementation of new and revised labels.Responsibilities: Essential Duties
Expertise: Knowledge & Skills
- Coordinate labeling development process for assigned product lines:
- Initiate/review label requests and obtain background information for label creation. Initiate label changes for compliance with new or revised company/regulatory requirements.
- Coordinate with various departments for creation of text for new labels layouts. Coordinate label translations.
- Assist in establishing standards, address text prominence, location of statements, and best fit arrangements.
- Ensure labeling is in compliance with Quality system requirements, GMP and applicable domestic and foreign regulatory requirements.
- Plan and prepare the appropriate Labeling documentation and labeling submission files such as NDA, ANDA, IND, 510(k), PMA, IDE, annual report, and drug listing filings.
- Participates on project teams as needed to provide labeling updates and information.
- Create or revise labeling and circulate labeling review package to obtain necessary approvals.
- Ensure labeling artwork generated is in conformance with dimensional specifications, color and design standards and proofread text. Generate final proof copy/transparency proof. Create print-ready artwork files.
- Serve as the primary information base for all issues related to product labeling.
- Evaluate problems that may occur in Label Release, Purchasing and Manufacturing. Take action as necessary to correct and solve problems; involve and assist management in investigation and resolution of problems as needed.
Qualifications: Expertise: Qualifications - Experience/Training/Education/Etc Required:
- Excellent English grammar
- Attention to detail, ability to adhere to project deadlines.
- Proficient in Microsoft Windows, Quark XPress, Adobe Acrobat and other graphics software.
- Good verbal and written communication skills, organizational skills, problem-solving ability, and multi-tasking skills.
- Good interpersonal skills.
- Must be able to work independently.
- Graphic design and layout.
- Completion of two- or four-year degree in graphic design or related field with minimum of 5 years job experience.
- 1-2 years experience in pharmaceutical or medical device company relating to labeling or regulatory affairs.
- Familiarity with regulatory agencies' labeling requirements.
- Any additionally experience, training, education or certification relating to the skills listed below.
- Certification and/or training in graphics software.
- Knowledge of regulatory agency requirements for labeling of a range of medical products for assigned product lines.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.
Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com Equal Opportunity Employer Minorities /Women/ Veterans/Disabled
Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.Other: Responsibilities: Other Duties:
The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.