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Global Labeling Operations Manager

Plats Warszawa, Masoviens vojvodskap, Polen Jobb-id R-090860 Datum inlagd 09/23/2020

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



AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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