Job Description

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation \xe2\x80\x93 ultimately providing employees with the opportunity to work across teams, functions and even the globe.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Our dedication to sustainability is also central fit to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we\xe2\x80\x99re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

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\xe2\x80\x99s 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

Great People want to Work with us! Find out why:

Are you interested in working at AZ, apply today!

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing .

Date Posted 28-Nov-2023

Closing Date 09-Dec-2023

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