FierceBiotech and FiercePharma Jobs
Labeling Manager - Bayer
Jan 25
Location: Montville, NJCategories: Pharmaceutical
Position Description
Bayer HealthCare (BHC) makes an important contribution to human and animal health with its innovative products and by researching new therapeutic approaches. Our Specialty Pharmaceutical business ranks among the top 10 specialty pharmaceutical companies worldwide. Our global research and development is focused in five distinct areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Specialized Therapeutics, and Women’s Healthcare. As a specialty pharmaceuticals company, we at Bayer HealthCare focus our efforts where we can have the most impact. Our Diabetes Care division is one of the largest self-test diagnostic businesses in the world, supporting customers in 100 countries. Our Consumer Care business is a top competitor in many important product categories including analgesics, cough and cold, and nutritionals. More than 3,000 employees support 14 manufacturing sites in 11 countries dedicated to ensuring the delivery of a secure, high-quality, cost-effective supply of our products around the world. Our Animal Health business in North America is dedicated to making the world a better place for our veterinary customers, their clients, and the animals we all hold dear.
Job description
Manages the creation and/or review process as it pertains to the design,
development and labeling of products distributed to the U.S. market both
at company and contract manufacturing/packaging facilities.
1. Manages the review and approval process for internal and external
manufacturers to ensure accurate, FDA and BHC compliant labeling for all
products within the U. S. market.
2. Manages the creation and review of contract
manufacturers’/packagers’ labeling documentation to ensure FDA & BHC
guidelines are followed. This includes maintenance of active and
archive information related to such activities for audit purposes.
3. Manages the creation and review of printed Packaging
materials/components from all sources for the U. S. Market, ensuring
that FDA and BHC labeling guidelines are adhered to.
4. Responsible for graphics design and developers compliance with
all FDA and BHC labeling requirements.
5. Interfaces with other departments within Bayer Schering Pharma
and other 3rd party suppliers to ensure generation of labeling needed
for NDA annual reports and SNDA’s (Changes Being Effected).
6. Responsible for ensuring accurate records of labeling changes for
submission with NDA annual reports. This includes obtaining all relevant
labeling changes from 3rd party manufacturers/packagers.
7.Follows all SOP’s relating to the creation and/or review process as
they pertain to labeling.
Prioritizes workload in order to create speedy and cost effective
resolutions to labeling changes
Qualifications
Education: BS/BA degree with a minimum of 6 years of proven packaging
and labeling experience.
Experience: In depth knowledge of CFR requirements as they pertain to
labeling compliance. In addition the incumbent must have a broad
knowledge of manufacturing and packaging and development processes and
must be able to provide quality expertise relative to these functional
areas.
Benefits
We offer a wide variety of competitive compensation and benefit programs. In addition to a competitive base salary, you will be eligible for an array of innovative rewards and recognition programs, variable pay and incentive opportunities as well as benefits coverage beginning on your first day of employment. We are committed to helping our employees maintain a healthy balance between their responsibilities at work and home. You will be eligible for paid time off programs, paid company holidays, flexible work options and numerous site conveniences. We are also committed to supporting your professional development through career ladders, training programs, tuition assistance and professional association events.
