Manager, Scientific Writing Support Services- CMC

at  AstraZeneca

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.

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.
The incumbent is responsible for business administration, development of procedures and /or mentorship, training materials, support using of the Information Management System (RIMS) used for authoring, review and approve regulatory submission content and tools used globally across the BPD functions.
The individual will interpret and ensure compliance with regulatory agency requirements and AstraZeneca standards as pertains to the format and submission readiness of regulatory documentation.
Main Duties & Responsibilities:

The individual will work closely with the 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
• 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 mentorship documents to support compliance delivers training and shares best practices with the team
• Performs pre-publishing QC on submission documents to meet up with the submission ready standards
• Manages BPD submission document templates in EDMS to follow AZ standards

The incumbent will be responsible for the 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
• Knowledge around Structured Content Authoring tools and other technical solutions to meet the future needs of the regulatory submission deliverables
• Technical enthusiast who has some exposure towards Gen AI tools such as ChatGPT and Copilot

EDUCATION & EXPERIENCE REQUIREMENTS:

Education: Bachelor’s degree, preferable in a science and technology 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 working with Microsoft office tools (including sophisticated 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 interpersonal 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 (no more than 6 bullet points; NICE to have 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 and Quality checking of Scientific Data

• 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
• Knowledge around Structured Content Authoring tools and other technical solutions to meet the future needs of the regulatory submission deliverables
• Technical enthusiast who has some exposure towards Gen AI tools such as ChatGPT and Copilo