Senior Specialist, Artwork & Label Development
Company: bluebird bio
Posted on: January 27, 2023
ABOUT THE FLOCK
Amazing opportunity to join the team that drives Artwork
Development, Traceability and Supply Chain Systems within the
Patient Supply organization. Fly at the cutting edge of science and
be a part of an enthusiastic team of bluebirds and external
partners in bringing our approved Gene Therapy products to market,
supporting ongoing clinical trial activity and getting ready for
launch of the next Gene Therapy. In this role you will work closely
with leaders and stakeholders within Apheresis Operations, Therapy
Operations and Customer Service, Manufacturing, Quality, Business
systems, Regulatory and External Partners and Suppliers.Through
strong collaboration with this cross functional flock of
stakeholders, this role will support the design and management for
commercial and clinical artwork.
HOW YOU'LL FLY
You'll help to bring more patients their bluebird days by:
- Driving clinical and commercial label design activities.
Including, but not limited to, creating labeling/packaging artwork,
preparing associated specifications, managing related electronic
labeling systems, managing quality systems activities (e.g. change
control) and coordinating printing of artwork components for raw
and starting materials, clinical product and commercial
- Reviewing and approving artwork for accuracy, regulatory
requirements and production requirements.
- Developing solid relationships with external artwork and print
- Work closely with external artwork and print suppliers to
ensure timely readiness of artwork development as well as timely
availability of printed components.
- Participating in initiatives to enhance labeling design, and
associated processes and systems.
- Working with cross functional stakeholders including Regulatory
Affairs, Quality Assurance, Commercial, Legal, Packaging
Engineering, Manufacturing and external partners to collect
content, develop artwork, coordinate supply of artwork components
and to further refine the process for design & development of
clinical and commercial labeling.
- Leading creation, review, update (as needed) and approval of
functional SOPs and Work Instructions.
- Ensuring budget, Purchase Order creation and invoice payments
occur on time.
WHAT YOU'LL BRING
You're the bird we're looking for if you have:
- 3+ years of experience in the biotech/pharmaceutical device or
diagnostic industry including at least 2 years of label design,
regulatory affairs or equivalent experience
- Experience with NiceLabel software.
- Strong understanding of FDA regulations and guidelines with the
ability to interpret them and a good understanding of GxP label
- Knowledge of FACT/JACIE and ICCBBA Standards
- Excellent attention to detail, project and time management
skills, and the ability to manage multiple priorities with
- Experience with clinical and marketed product labeling, patient
information leaflet design
- Knowledge on how to author Standard Operating Procedure
documents is a plus.
Keywords: bluebird bio, Somerville , Senior Specialist, Artwork & Label Development, Other , Somerville, Massachusetts
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