Manager, Scientific Writing Support Services

Join our Biopharmaceutical Development (BPD) Scientific Writing (SW) team as a Manager, Scientific Writing Support Services. Reporting to the Director, Scientific Writing, you will be responsible for business administration, developing procedures and guidance, creating training materials, and providing end-user support for the Regulatory Information Management System (RIMS). This system is crucial for authoring, reviewing, and approving regulatory submission content and tools used globally across BPD functions. You will ensure compliance with regulatory agency requirements and AstraZeneca standards regarding the format and submission readiness of regulatory documentation.

**What you'll do**:

- Work closely with BPD Scientific Writers to deliver timely Quality submission documents.
- Generate and manage the ICH M4Q regulatory submission components and data within the relevant EDMS ensuring completeness according to submission plans.
- Represent the SW team in discussions for submission standards, structures, and formats. Communicate and advise upon submission document structure and format requirements to the Scientific Writing team, develop processes and guidance documents to support compliance, deliver training, and share best practices within the Scientific Writing group.
- Perform pre-publishing QC on submission documents to meet submission-ready standards.
- Manage BPD submission document templates in EDMS to meet AZ standards.

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

- EDMS 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 the business community.
- Knowledge around Structured Content Authoring tools and other technical solutions to meet future needs of regulatory submission deliverables.
- Technical enthusiast with some exposure to Gen AI tools such as ChatGPT and Copilot.

**Essential Skills/Experience**
- Education: Bachelor’s degree, preferably in a science and technology discipline.
- Experience: 2-4 years of biopharmaceutical industry experience, preferably within a CMC document submission related area.
- Experience working within validated EDMS with a clear understanding of document management best practices and familiarity with SharePoint, preferably as a site owner or above.
- Proficient in working with Microsoft Office tools (including advanced Word formatting skills), SPOL, Gen AI tools such as ChatGPT and Copilot.
- 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).

**Desirable Skills/Experience**
- 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 and Quality checking of Scientific Data.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we are committed to making a difference by fusing data and technology with the latest scientific innovations. Our dedication to helping more patients drives us to strengthen our pipeline and grow our area. We harness digital, data science & AI to fast-forward our research, ensuring that work born in a lab can make a real difference in patients' lives across the world.