Global Labeling Operations Manager

Job Description

The Global Labeling Delivery Manager/Associate Director is responsible for document management of EU and US labeling for assigned marketed and/or pipeline products. This includes delivering high-quality, submission ready documents according to required timelines, managing the EU linguistic review process and authoring content of labeling for US SPL submissions.

Accountabilities/Responsibilities:

• Ensure all work is performed in accordance with established procedures, regulatory requirements and GxPs.
• Provide support to Global Labeling Strategist with regards to labeling documents for submission
• Provide guidance to labeling teams regarding regulatory technical requirements for regional labeling submissions
• Manage labeling submissions for US and EU, including QC, proofing, copy editing and formatting of documents, and coordinate review and approval of final submission documents
• Understand industry labeling trends related to labeling and submission guidance and directives
• Interpret regional labeling regulations and guidance, determining company impact and providing comments as appropriate
• Liase with Global Labeling Strategy and RPM to advise/recommend submission best practices
• Contribute the regulatory labeling perspective in support of submission delivery
• At the request of Labeling Strategist, originate precedent searches, create and maintain labeling comparisons
• Interact with Marketing Company colleagues regarding linguistic review and translations
• Oversee and coordinate EU linguistic review process as appropriate
• Interact with appropriate functional groups to obtain labeling annotations and supporting documentation
• Author Content of Labeling/Drug Listing SPL file
• Generate and validate SPL file for submission
• Draft summaries of relevant labeling changes for PSURs, Annual Reports and other periodic reports
• Maintain labeling lifecycle of documents and ensure proper naming according to DNC
• Coordinate with Regional Regulatory staff to deliver submission ready documents and ensure submission timelines are met
• Assist in responding to labeling-related queries from various functional areas
• Assist Global Labeling team in resolution of labeling issues as needed
• Participate in the development and maintenance of work practices, templates, and associated documents relating to the labeling function
• Liaise with senior management as needed to resolve critical labeling issues
• Represent functional expertise at relevant department meetings and relevant cross functional subteams

Essential

• Minimum requirements:
• University Degree in Science or related discipline
• 1 to 3 or 3 to 5 years (depending on role) pharmaceutical experience, preferably regulatory experience, preferably working with labeling
• Knowledge of labeling regulations and guidances
• Keen attention to detail and accuracy
• Excellent verbal and written communication skills
• Multi-cultural awareness and sensitivity; demonstrated experience effectively communicating and negotiating in diverse cultures.
• Ability to think strategically, appropriately assess risks and formulate strategies to manage risk
• Must demonstrate competencies in:
• Building Relationships (works well across formal and informal networks)
• Negotiation Skills (good listener; able to build a consensus)
• Critical Information Seeking (works well across formal and informal networks)
• Rational Persuasion (able to distil an issue to its key components and suggest solutions)
• Interpersonal Awareness (aware of how actions affect other people)

Preferred Background:

Experience in packaging labeling development and/or maintenance