B. Braun

  • Associate Director, Labeling Development & Product Identification

    Job Locations US-PA-Allentown
    Requisition ID
    2018-12846
    Company
    B. Braun Medical Inc
    # of Openings
    1
    Category
    Manufacturing
    Position Type
    Regular Full-Time
    Shift
    8am - 5pm
    Site
    Corporate/Sales/ B. Braun of Canada/ BIS/ CeGat
  • Overview

    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:

     

    Management of the Labeling department for the medical device and pharmaceutical divisions. This includes insuring the establishment of labeling standards, systems and direction/guidance for label development to meet regulatory requirements. Prepare labels and related support documentation for regulatory submissions with minimal supervision. Manage the creation, review, approval, and implementation of new and revised labeling in accordance with applicable regulations and policies. Coordinate with external vendors, manufacturing, purchasing, and QC to ensure ordering, receipt, and implementation of new and revised labels for drug and device products.

     

    Responsibilities: Essential Duties

    • Definition of label development process and lifecycle management of labeling to include design inputs, regulations, establishment of standards and change control. Develop and maintain department SOPs.
    • Manage work assignments of Labeling Specialists, performance management, development, coaching, training, and application of policies, programs and procedures.
    • Manage label software system maintenance, upgrades, and identification of future requirements.
    • Manage capital requests and budgeting for labeling processes and systems.
    • Review label requests and obtain background information for label creation.
    • Create labeling as needed for implementation of new or revised labeling.
    • Ensure labeling is in compliance with applicable domestic and foreign regulatory requirements.
    • Ensure labeling documentation quality.
    • Review labeling documents for general quality of printing and conformance to appropriate standards and master specifications.
    • Define method for maintaining complete and accurate sample, master and history labeling files. Maintain complete and accurate sample, master and history advertising files.
    • Define process for label documentation deliverables needed by Regulatory Affairs for submission to regulatory agencies.
    • Submit requests for label translations.
    • Serve as the primary information base for all issues related to product labeling. Take action as necessary to correct and solve problems.
    • Interact with Purchasing to ensure orders, reorders, notify them of label changes and current label version. Authorize Purchasing to order negatives and release negatives to vendors.
    • Initiate label changes for compliance with new or revised company/regulatory requirements.
    • Plan and prepare the appropriate Labeling section of submissions such as NDA, ANDA, IND, 510(k), PMA, IDE, annual report and annual drug listing filings. Provide labeling support as needed for interactions with regulatory authorities.
    • Establish and maintain electronic labeling files to support product development and maintenance.

    Expertise: Knowledge & Skills

    • Attention to detail and quality, ability to adhere to project.
    • Proficient in Microsoft Windows, Quark, Adobe, and other graphics software.
    • Good verbal and written skills.
    • Organized, able to manage multiple projects, shifting priorities, problem solving ability and ability to take initiative.
    • Ability to understand and interpret regulatory requirements, and translate this understanding into solid decision making.
    • Good interpersonal skills.
    • Ability to drive projects to completion with minimal oversight.
    • Graphic design and layout.

    Qualifications

    Expertise: Qualifications - Experience/Training/Education/Etc

     

    Required:

    • Completion of two or four year degree in graphic design, regulatory, quality or related field or equivalent job experience.
    • At least five years experience in a pharmaceutical or medical device company relating to preparation of labeling or regulatory.
    • Experience and familiarity with regulatory agencies’ labeling requirements.
    • Supervisory or management experience.
    • Certification and/or training in graphics software.
    • Solid command of GMP regulations and labeling regulations required.
    • Understand context and content of label development.
    • Both problem solving, decision making and negotiating skills are required to the extent that regulatory submissions impact B. Braun's product registrations and filings. Critical decisions would be reviewed with supervisor prior to implementation.

    Desired:

     

    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.

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