Do you have a passion for Science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
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.
About AstraZeneca in Gaithersburg, MD:
Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.
The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you'll find newly-designed, activity-based work spaces to suit a variety of working styles while increasing collaboration between teams.
Summary of the group:
Scientific Writing Support Services (SWiSS) team is an integral part of the Scientific Writing and CMC Project Management Group. The team is responsible for supporting scientific writers in the delivery of biopharmaceutical CMC submission contributions for development (CTA) through to Marketing Authorizations (BLA) submissions. Additionally the group represents cross-functional Biologics users in the development and functional governance of our global Regulatory Submissions Document Management tool and Development Reports Repository and provides technical expertise and end user support for these systems.
Main Duties & Responsibilities:
Education & Experience Requirements:
- Is responsible for timeliness and quality of regulatory submission deliverables within the areas of Module 3 Virtual Document Structure creation, literature reference sourcing and preparation, document formatting and submission readiness, hyperlinking and PDF readiness activities to ensure documents are compliant with global regulatory authority and AstraZeneca standards.
- Establishes team resource needs and timelines for assigned project. Liaises with team and management to secure resource as needed.
- Is a submission documentation and/or EDMS subject matter expert. Communicates and advises upon submission document structure and format requirements: develops standards, processes & guidance documents. Manages templates, ensuring technical compliance for documentation and delivers training and shares best practices.
- Contributes to the efficient operation of the Scientific Writing Support Services and broader Scientific Writing group through continuous enhancement of the operating model, process and tools. Participates and may lead team and functional, business improvement projects as appropriate.
- Ensures AstraZeneca, BPD and scientific writing systems / tools meet the business needs of the Scientific Writing and broader BPD biologics business area through participation in requirements gathering and tool evaluation; development of operating processes; performing user acceptance testing / validation activities.
- Responsible for the business administration and end user guidance and support for the following tools utilised within Biopharmaceutical Development including: ANGEL Document Management System, BPD ANGEL Business continuity SharePoint site, BPD Reports system (eHive), BPD Scientific Writing SharePoint Site and CAP including site creation and maintenance, evaluation and enhancement
Bachelor's degree or 2-4 years equivalent industry-relevant experience, preferably within a CMC document submission related areaRequired Skills:
- Understanding of CTD (Common Technical Document) content and formatting standards to ensure submission compliant documentation
- Proficient in Microsoft office (including advanced Word formatting skills)
- Experience working within validated electronic document management systems with clear understanding of document management best practices
- Knowledge of the drug development process
- Experience working with global teams
- Ability to work within a matrix team environment
- Familiarity with SharePoint, preferably as a site owner or above
- Understanding of CFR21 part 11 requirements and other global standards
- Experience with PDF editing tools (e.g. Adobe Acrobat DC Pro and related add in PDF manipulation tools)
- Experience with EndNote
- Global Regulatory Submission Publishing knowledge
- Project Management Skills
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.So, what's next!
Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it's yours.Where can I find out more?
Check out our landing page for more information on our BPD group https://careers.astrazeneca.com/bpd
Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
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