Operations Manager, Clinical Regulatory Writing

Join a place built on innovation and creativity. Where different views and perspectives are welcomed and valued. An environment that champions inclusion, and teams that reflect the diversity of the communities that we serve.

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. Be encouraged and supported to think creatively in our dynamic environment. Here we are free from fear of failure, free to ask the right questions and make bold decisions.

Within Clinical Regulatory Writing, we provide expert communications leadership to drug projects and author strategically important clinical-regulatory documents that align with project strategies, regulatory requirements, and communications best-practices. We support the Company's core therapeutic areas in all phases of clinical development. Our vision is to be an industry leading organization driving strategic communication excellence to achieve successful submissions and approvals.

We are currently looking for a Clinical Regulatory Writing Operations Manager to join our team.

What you'll do
The Clinical Regulatory Writing Operations Manager manages multiple operational aspects of the Clinical Regulatory Writing (CReW) group. Responsible for overseeing and managing planning, compliance, cross-functional collaborations, vendor management and clinical-regulatory document quality control (QC) documentation requirements. Typically dealing with the administration of Purchase order management with multiple service providers. The position belongs to the CReW Business Planning, Operations and Vendor Management team.


Responsibilities include:

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Manage Purchase Orders and invoice tracking
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Assist with vendor training oversight as well as vendor access tracking
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Perform expedited business-critical QC requests
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Handle literature references process (collection, copyright, and publishing)
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Being able to QC documents according to AZ QC documentation requirements
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Collaborate cross-functionally and contribute to continuous improvement within CReW and across the organization


Essential for the role:

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High School Diploma required
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Excellent communication skills
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Good organization and administration skills
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Proficiency in English
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Proficiency in Microsoft Office


Desirable for the role:

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Clinical Regulatory Document management
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Procurement or Process management
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MS Sharepoint skills


So, what's next?
If this sounds like your next challenge - apply today!
We look forward to get to know you better. Please send your application to us no later than May 24th.



Why AstraZeneca?
At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. 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 Gothenburg site is one of AstraZeneca's three strategic R&D centers. With more than 2,400 employees from over than 50 countries, our vibrant Gothenburg site is a truly inspiring place to work. Here, the history and future of scientific breakthrough come together. We believe that the diversity of our people is crucial to bringing new discoveries to life.

There are many opportunities to develop yourself and your career at AstraZeneca and you will have support to develop to more senior roles within the company.

You will be offered a competitive salary and excellent benefits, such as extra paid Holiday, Private Medical Benefits, On-site exercise and much, much more.



Where can I find out more?

About BioPharmaceuticals R&D: https://www.astrazeneca.com/r-d.html

Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

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Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en QC orders handled by external vendors.