Senior CMC Documentation Lead, Pharmaceutical Technology & Devel
Poolia Göteborg AB / Apotekarjobb / Göteborg
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hela Sverige Are you looking for a new job career challenge within Regulatory Affairs and project management? Then you might be the consultant AstraZeneca are looking for! As a CMC Documentation Lead you will be a key member of the project team and have an opportunity to develop a deeper understanding of the regulatory processes, see the full range of pharmaceutical development documentation provided to authorities and lead cross functional teams. The consultant assignment will start 2018-04-01 and go on to 2019-10-31 to start with. Next step, apply today!
about the consultant assignment
The arena
AstraZeneca is a global, science-driven biopharmaceutical company. We are dedicated to discovering, developing, and delivering innovative, meaningful medicines and healthcare solutions that enrich the lives of patients. Pharmaceutical Technology and Development (PT&D) are the bridge, which turns brilliant science into actual medicines that help millions of people. We work across the entire value chain, designing and delivering active ingredients, formulations and devices required to support new medicines for use in early toxicology studies and clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture.
The role
We now have a position available for an individual who shares our passion to join the Regulatory Documentation team in Gothenburg or in Macclesfield. Documentation for the Chemistry, Manufacturing and Controls (CMC) part of submissions is one of the key project deliverables from Pharmaceutical Development (PT&D and Pharm Sci). The CMC Regulatory Documentation supports clinical trials and marketing applications to obtain our commercial manufacturing license. As a CMC Documentation Lead you will be a key member of the project team and have an opportunity to develop a deeper understanding of the regulatory processes, see the full range of Pharmaceutical Development documentation provided to authorities and lead teams across PT&D, Pharm Sci and regulatory departments in R&D and Operations.
Role responsibilities
• Accountable within Pharmaceutical Development for the production and delivery of CMC sections of all regulatory documents e.g. marketing and clinical study applications, responses to Health Authority questions and briefing documents. The major tasks include
o Define which CMC documents are required
o Prepare for and run the CMC Submission Kick Off meeting
o Lead the delivery team (authors, reviewers, approvers) for the CMC part of submissions
o Lead the review process for all CMC documents, consolidating all comments
o Drive the completion and on-time approval of all CMC documents to submission ready standards
Who you are
Minimum requirements
• A University degree preferably Chemistry or Pharmacy
• Proven experience working in a science area with the drug development process involving regulatory documentation using Document Management Systems, e.g., ANGEL
• Expert understanding of the pharmaceutical industry, drug development process, AZ departments and how they contribute to AZ processes to fulfill regulatory requirements.
• Demonstrated strong interpersonal, motivational and leadership skills
o A 'can-do' attitude
o Independent and calm under pressure
o Confident leader and a clear communicator at ease of communicating with senior leaders
o Results-focus and ability to deliver projects
o Demonstrated ability to set and manage priorities, resources, goals and project initiatives.
• Excellent written and verbal in English
• Evidence of acting decisively, collaborative working, strategic leadership, commitment to customers and integrity, driving accountabilities with people at all levels and within drug product delivery teams.
About Poolia & AstraZeneca
Poolia take good care of our consultants and we offer social activities, as well as help in planning your future career. Your consultant manager is well experienced from your field, and knows how to get the most out of your assignment. As a Poolia employee, you are included in the requirements concerning agreements on terms of employment by Unionen. Moreover, you get a grant for working out at your choice of place. You are also covered by a health insurance.
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. AstraZeneca is one of the world's leading pharmaceutical companies. At AstraZeneca, we promote a culture that inspires innovation and collaboration.
Next step, apply today!
Varaktighet, arbetstid
Heltid Sex månader eller mera
Publiceringsdatum2018-02-20ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2018-02-27
Ange följande referens när du ansöker: 49496
Klicka på denna länk för att göra din ansökanFöretagPoolia Göteborg AB
AdressPoolia Göteborg AB
Kungsgatan 42
41115 Göteborg
KontorsadressKungsgatan 42
Jobbnummer 3977348
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