Manager, Scientific Writing Support Services

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.

This position can sit in Gaithersburg, MD OR Macclesfield UK

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 workspaces to suit a variety of working styles while increasing collaboration between teams.

Summary of the group

The Manager, Scientific Writing Support Services role functions as a member of the Biopharmaceutical Development (BPD) Scientific Writing (SW) team, reporting to the Director, Scientific Writing.

Responsible for business administration, development of procedures and /or guidance, training materials, and end user support for the use of the Electronic Document Management System (EDMS) used for regulatory submissions, authoring tools, and tools used globally across BPD functions, Regulatory CMC (biologics) and Development Quality Biologics.

Interprets and ensures compliance with regulatory agency requirements and AstraZeneca standards as pertains to the format and submission readiness of regulatory documentation.

With BPD Scientific Writers supervision, supports the preparation of the Quality module of biologics regulatory submissions for clinical trials and marketing applications.

Main Duties & Responsibilities

Works closely with the BPD Scientific Writers to deliver timely Quality submission documents:

• Generate and manage the module 3 regulatory submission components and data within the relevant EDMS ensuring completeness according to submission plans
• Performs pre-publishing QC on submission documents to meet the submission ready standards
• Represents the SW team on discussions for submission standards, structures and formats. Communicates and advises upon submission document structure and format requirements to the Scientific Writing team, develops processes and guidance documents to support compliance delivers training and shares best practices within the Scientific Writing group
• Manages BPD submission document templates in EDMS to meet the AZ standards

Responsible for the business administration and end user support for the business tools utilized within Biopharmaceutical Development. Ensures AstraZeneca, BPD, and scientific writing systems / tools meet the business needs of the Scientific Writing and broader BPD biologics business area through:

• EDMS in compliance with AZ global and functional standards, procedures and processes
• BPD System Business continuity SharePoint site including development, maintenance of site, operating standards and processes, and training
• Participation in requirements gathering, tool evaluation, user acceptance testing / validation activities
• Supporting development of operating processes, training materials and roll out of new capabilities to business community

Education & Experience Requirements:

Education: Bachelor’s degree, preferable in a science discipline

Experience: 2-4 years of bio pharmaceutical industry experience, preferably within a CMC document submission related area

Required Skills

• Experience working within validated EDMS with clear understanding of document management best practices and familiarity with SharePoint, preferably as a site owner or above
• Proficient in Microsoft office (including advanced Word formatting skills)
• Ability to work within a matrix team environment along with good prioritization and multi-tasking skills
• Good communication skills, both in writing and oral
• Experience in the authoring and review of technical documents
• Proficient in PDF editing tools (e.g. Adobe Acrobat DC Pro and related add in PDF manipulation tools)

Desired Skills

• Understanding of CTD (Common Technical Document) content
• Familiarity with CFR21 part 11 requirements and other global standards
• EndNote and Global Regulatory Submission Publishing knowledge
• Experience working with global teams along with some Project Management skills
• Knowledge of the drug development process
• Quality checking of Scientific Data

Why AstraZeneca?

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?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.