Senior CMC Documentation Lead
AstraZeneca AB / Biomedicinjobb / Göteborg
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hela Sverige At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.
We are now recruiting Senior CMC Documentation Leads to join our Chemistry, Manufacturing and Controls (CMC) Documentation team in Pharmaceutical Technology and Development at Gothenburg, Sweden.
Pharmaceutical Technology and Development (PT&D) is the bridge which turns forward-thinking science into actual medicines that help millions of people. We work across the entire value chain, crafting and delivering active ingredients, formulations and devices required to support new medicines - from supplies for use in clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture.
The CMC Documentation Group play a key role in ensuring that AstraZeneca's CMC regulatory submissions for both clinical trials and marketing applications are delivered. We keep pace with the evolving external regulatory environment, and exciting CMC science to ensure delivery of key CMC regulatory documentation for our exciting portfolio.
The group manages a harmonised and effective authoring, review, approval and publishing process for the CMC elements of submissions and has accountability for the deliveries from Pharmaceutical Technology & Development (PT&D) and Pharmaceutical Sciences (PharmSci) to Regulatory Affairs.
Part of an inclusive and giving community, we support and help each other on our journeys -backed by the same personal commitment to each other as we give to patients. Curious problemsolvers, we are intellectually stimulated by constant learning. There's potential for multiple, global careers and great rewards, for those who embrace the diverse opportunities.
What you will do?
In this role you will support clinical trials for phase 1 to phase 4 and marketing applications to obtain our commercial manufacturing license.
As a CMC Documentation Lead you will be a key member of the CMC 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.
You will be accountable for leading 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.
Your main responsibilities will include:
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Defining which CMC documents are required
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Preparing and running the CMC Submission Kick Off and review meetings
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Leading the delivery team (authors, reviewers, approvers) for the CMC part of submissions
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Leading the review process for all CMC documents, consolidating all comments
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Driving the completion and on-time CMC approval of all CMC documents to submission-ready standards
Required Skills
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A University degree, preferably Chemistry, Pharmacy or related natural science degree
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Experience using document management systems, e.g. CARA
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Good understanding of the pharmaceutical industry and the drug development process
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Excellent written and spoken English
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Experience of leading teams
Desired Experience
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Experience of managing delivery teams and CMC regulatory documentation in a pharmaceutical company
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Experience of medical devices, combination products, inhaled products or new modalities
To be successful in this role we believe that you have a can-do attitude and an ability to set and manage priorities, resources and project initiatives.
Why AstraZeneca
At AstraZeneca we're dedicated to being a Great Place to Work. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.
Our stunning campus in Gothenburg is one of AstraZeneca's three strategic science centers. The site is home to over 2,500 employees, from 50 different nationalities. Gothenburg includes the complete range of functions, and as such offers plenty of development opportunities for a wide range of professionals. Our science teams in Gothenburg collaborate with academic and industry partners in Sweden and globally. And the site itself has been designed with collaboration in mind. From the Coffee Lab to exercise areas, we've built a series of environments where innovation can happen.
So what's next!
If this sounds like the next challenge for you - apply today!
We look forward to your application no later than June 28, 2021.
For more information about the position your are welcome to contact Birgitta Larsson, tel +46 (0)709131217.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2021-06-11ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2021-06-21
Klicka på denna länk för att göra din ansökanFöretagAstrazeneca AB
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "R-110861".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Astrazeneca AB (org.nr 556011-7482)
Arbetsplats AstraZeneca
Jobbnummer 5805014
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