Submission & Lifecycle Manager
Alten Sverige AB / Biomedicinjobb / Göteborg
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hela Sverige The Global Labeling Delivery Manager 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.
EDUCATION, QUALIFICATIONS, SKILLS AND EXPERIENCE:
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
Welcome to send in your application, we look forward to getting to know you.
Varaktighet, arbetstid
Heltid Tillsvidareanställning
Publiceringsdatum2021-03-02ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2021-03-11
Klicka på denna länk för att göra din ansökanFöretagAlten Sverige AB
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Alten Sverige AB (org.nr 556420-7453)
Jobbnummer 5603064
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