What are the responsibilities and job description for the AstraZeneca GmbH is hiring: Manager, Scientific Writing Support Services in Gait position at AstraZeneca GmbH?
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.
Keep a pulse on the job market with advanced job matching technology.
If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution.
Compensation Planning
Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right.
Surveys & Data Sets
What is the career path for a AstraZeneca GmbH is hiring: Manager, Scientific Writing Support Services in Gait?
Sign up to receive alerts about other jobs on the AstraZeneca GmbH is hiring: Manager, Scientific Writing Support Services in Gait career path by checking the boxes next to the positions that interest you.
Not the job you're looking for? Here are some other AstraZeneca GmbH is hiring: Manager, Scientific Writing Support Services in Gait jobs in the Gaithersburg, MD area that may be a better fit.
We don't have any other AstraZeneca GmbH is hiring: Manager, Scientific Writing Support Services in Gait jobs in the Gaithersburg, MD area right now.
