Full-Time Senior Associate Labeling Operations
The Labeling Operations Associate (LOA) serves as the regulatory contact for labeling operations activities for marketed and new (launch) products. The LOA manages operational support for the initial creation and relevant updates to labeling documents which may include product label (e.g., carton, vial), prescribing information (e.g., SPL/XML), and patient information (e.g., Medication Guide).
Additionally, he/she is responsible for the development and maintenance of label operations systems including the integration of a new cloud based label management systems (i.e., GLAMS). The LOA will lead internal/vendor working groups to establish best practices and implement compliant processes.
The LOM provides/oversees project management to the Labeling Team throughout the label review and approval processes to ensure that these documents are produced in a timely manner according to internal SOPs and external regulatory requirements. This includes setting clear targets, ensuring that Labeling Teams are aware of the review and approval timelines and following up with Labeling Team members throughout the process as appropriate so that deliverables remain on target to meet internal and external deadlines.
Support the use and development of current and new tools, technologies and processes to support global label development, submission and approval.
Management of drug listing and establishment information in SPL by working effectively with vendors.
Prepare summary of labeling changes (including components and revision/version information) during a given reporting period for inclusion in an Annual Report and/or PADERs.
Management of NDC Labeler Codes
Assist in the preparation of detailed monthly reports (if applicable)
Provide support to Strategic Global Labeling and Regulatory functions through document management and other group management activities as required.
Act as a support for local, regional and multi-country regulatory labeling requirements.
Provide product labeling proofreading support, as necessary.
Ensure product labeling reporting alignment with CFR and internal requirements.
Manage and maintain documents, project tracking, distribution lists, etc.in electronic document management system and SharePoint site.
Respond to e-mail queries related to activities associated with assigned projects to ensure accurate daily workflow.
Review/Approval of final artwork.
Anticipate regulatory labeling obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
Experience / Skills:
2-4 years’ experience in the pharmaceutical industry with a focus in regulatory labeling area
Strong knowledge of FDA with regard to drug labeling activities
Knowledge of other international Health Authority drug labeling requirements (e.g., Canada, EU, Japan, and Australia) not required, but a strong plus.
Strong knowledge of SPL required
Experience in package labeling development and implementation
Ability to prioritize, manage multiple projects and meet project timelines
Excellent verbal and written communication skills as well as strong interpersonal skills
High attention to detail
Work effectively with minimal supervision
How to ApplyIf interested and qualified, please visit the below link to apply: https://mallinckrodt.wd5.myworkdayjobs.com/MallinckrodtCareers/job/US-Specialty-Brand-Headquarters---USA501/Senior-Associate--Labeling-Operations_JR000010108-1
46 total views, 1 today