Manager, Regulatory Information
Poolia Sverige AB / Säljarjobb / Göteborg
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hela Sverige We are now looking to recruit a Regulatory Information Manager within Global Regulatory Operations at AstraZeneca in Gothenburg. The consultant assignment will start as soon as possible and continue until 2020-07-31. You will be primarily responsible for supporting the management, collection, coding and analysis of the Global Product Registration List; regulatory data standards (XEVMPD, IDMP); and regulatory information. To be considered for this exciting opportunity, please complete the application at your earliest convenience. If you know someone who would be a great fit, please share this posting with them.
Publiceringsdatum2019-10-29Om tjänstenGlobal Regulatory Operations (GRO) manages several parts of Regulatory Information Management (RIM) within AstraZeneca. GRO has the expertise and provide the tools and services to be able to meet:
• The ever-increasing complexity of regulations and product portfolios
• Growing demand for data due to increased public and regulatory scrutiny
• Global collaboration and standardization of formats and processes across the markets
• Increased use of partners and outsourcing
The Manager, Regulatory Information is primarily responsible for supporting the management, collection, coding and analysis of the Global Product Registration List; regulatory data standards (XEVMPD, IDMP); and regulatory information. This is a temporary assignment lasting until 31st of July 2020.
Dina arbetsuppgifter i huvudsak
• Manages the collection, coding and analyses of regulatory information for assigned products in accordance with regulatory data standards, quality control and quality improvement methodologies.
• Compiles and delivers XEVMPD or other regulatory information-based submissions to health authorities.
• Develops self in topic areas critical to successful delivery of the RI remit. Particularly, technical skills (XEVMPD, IDMP), knowledge of international regulations and skills (communication, project management).
• Engages with partners, affiliates, subsidiaries or other stakeholders to collect regulatory information and to ensure compliance with procedures and standards.
• Monitors the environment for changes in legislation related to regulatory information.
• Reviews and evaluates regulations, guidelines and technical specifications related to regulatory information processes and regulatory information data standards.
• Identifies opportunities for continuous improvement.
• Prepares business reports or alerts in response to business or health authority request.
• Ensures collection and coding of regulatory information is done in compliance with regulatory and pharmacovigilance legislation, regulatory processes and regulatory data standards.
Vem är du?
Minimum requirements:
• University degree in the life sciences or IT
• Experience in pharmaceutical/medical industry
• Knowledge of pharmaceutical drug development process
• Strong analytical and critical thinking ability
• Good understanding of current regulatory legislation, guidelines and trends relating to regulatory information (process, tools, standards)
• Able to manage productivity responsibilities
Preferred experience and key factors:
• Good problem and conflict resolution skills
• Ability to set and manage priorities, performance targets and project initiatives
• Ability to innovate best practices with business process analysis and design
• Ability to thrive in a rapid paced environment
Om verksamheten
AstraZeneca is a science-led, global biopharmaceutical company, with a focused portfolio in core therapies. We are committed to improving the health and lives of people across the globe, through our broad research and development platform, and a growing late-stage pipeline. Working in over 100 countries, we have strength in emerging markets, and our medicines are used by millions of patients and clinicians worldwide.
Varaktighet, arbetstid
Heltid Visstid, mer än 6 månader
ErsättningFast lön
Så ansöker duSista dag att ansöka är 2019-11-06
Klicka på denna länk för att göra din ansökanFöretagPoolia Sverige AB
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "55061".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Poolia Sverige AB (org.nr 556426-7655),
http://www.poolia.se Arbetsplats Poolia Väst AB
Jobbnummer 4892736
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