JOB TITLE : PLATFORM MANAGER

CAREER LEVEL: F

Leverage technology to impact patients and ultimately save lives

Do you have expertise in, and passion for, information technology? Would you like to apply your expertise to impact the IT strategy in a company that follows the science and turns ideas into life changing medicines? If so, AstraZeneca might be the one for you!

ABOUT ASTRAZENECA

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca we’re dedicated to being a Great Place to Work.

ABOUT OUR IT TEAM

It’s a dynamic and results-oriented environment to work in – but that’s why we like it. There are countless opportunities to learn and grow, whether that’s exploring new technologies in hackathons, or redefining the roles and work of colleagues, forever. Shape your own path, with support all the way. Diverse minds that work cross- functionally and broadly together.

ABOUT THE ROLE

• Analysing: Assess and document platform composition and condition, identify stakeholders and expectations on run (i.e., operations), exploit (e.g., requests) and new and current projects and issues.
• Defining: Define and develop the platform strategic, roadmap, LRP Planning including relevant performance measures, addressing current issues and challenges, future plans for changes and opportunities for improvement.
• Engaging: Proactively socialize the platform roadmap with business functions using the platform – and with other platform, process and partnership managers across IT. Collect feedback for improvement, ensure alignment and coordination, and avoid redundancy or conflicting demands.
• Operating: Execute on the platform roadmap, actively lead the platform as a set of interconnected assets and manage cross-platform dependencies. Present financial show back and planning associated with platform roadmaps in collaboration with IT Capability, BRMs.
• Evaluating: Assess the health and operational performance of the platform against established metrics. Achieve and improve operational service metrics and/or targets associated with platforms.
• Problem Solver/Critical Thinker: This role requires someone who can understand the issues, the broader context, and help to develop strategic and specific solutions.
• Technology Savvy: This role will be benefitted by an individual who is a quick learner and able to utilize different software technologies.
• Process Implementation & Improvement Experience: The ideal candidate will have experience creating, implementing, and improving global processes, particularly within regulatory operations and quality assurance.
• Executive Communication. Must communicate and present at the executive level: proficiency in partner buy in, strong multi-functional communication, organizational navigation, building rapport across functions and levels of management.
• Improving: Identify and realize opportunities to increase the value of the platform by extending cost-effective use and/or reducing platform costs through rationalization, consolidation, streamlining, and price negotiation.

ESSENTIAL SKILLS REQUIRED

Technical/Management Expertise:

• Consistent track record to collaborate with teams to help them understand the product’s key capabilities and benefits; understand their needs to enhance adoption of IT Solutions.
• Worked with customers and leaders to help in validating technical concepts, vision, and roadmaps.
• Experience working with the team to specify technical requirements for current and future products.
• Maintained program objectives, success measurements or key performance indicators (KPIs).
• Participated in release planning, demonstrations, and retrospectives with development teams.
• Previous experience in Agile Methodology for backlog tracking, burndown metrics, velocity, and task definition.
• Familiarity with common SaFe Agile practices, service-oriented environments, and better development practice.
• Mastery of complex facilitation and dependency management techniques (cross team, cross department).
• Handled cross team, ART and departmental impediments, planning, collaboration, and coordination.
• Driven delivery and continuous improvement by utilizing feedback and metrics (quality, delivery rate, etc.) to identify areas of opportunity.
• Experience working in IT GxP Validated environment adhering to good practices for – CSV (21 CFR Part 11, Annex 11 EU GMP, GAMP 5) including ITIL Service/Organizational Change framework.
• Consistent track record of working experience across different technology stack ranging for COTs, Cloud based SaaS vs On-prem, LAMP vs WAMP, SQL vs NoSQL, Multi-tier architecture Solutions.
• Experience working or knowledge related to TOGAF architecture and Ajax Web Development Framework.

Regulatory Information Management:

• Direct experience with systems such as Veeva Vault, PARAXEL/LIQUENT InSight, CSC Regulatory Tracker, ArisGlobal Register, OpenText, SharePoint, Documentum, FirstDoc/FirstPoint, NextDocs, CARA, Extedo eCTD Manager, TrackWise, or other RIM Solutions.
• Excellent technical understanding and confirmed, hands-on experience in technologies such as SharePoint, eCTD Publishing Tools (InSight Publisher/Viewer), Veeva Vault RIM, and off-the-shelf and plug-in software such as DXC Publisher, LORENZ eValidator.
• Solid understanding in developing Regulatory requirements, such as IDMP, XEVMPD for Regulatory Product data tracking, registration, eCTD for Publishing, SPL for Labeling IT Solutions.
• Experience to maintain or support a robust data foundation across Global Regulatory Affairs/Operations processes and systems.
• Knowledge about Submission Assembly (i.e. collecting Regulatory Documents and related data sets and creating a Submissions Package output, including experience with Electronic Common Technical Documents [eCTD]) across Health Authorities.
• Experience in GxP Document Content Management Applications used by Regulatory Operations.
• Experience with IT Systems for product labeling according to the requirements in domestic and international standards and regulations.
• Worked in enterprise wide implementation across multiple phases and workstreams (e.g. solution design and configuration, systems integration, data migration, validation, and training).
• Knowledge on full life-cycle development: IND/NDA/BLA/MAA/CTA/510K Submission types dossiers including component such as CMC, IMPD and related amendments to support the solution design in accordance with the industry regulatory regulations.
• Expertise in ICH-HL7 data standards of eCTD and IDMP, MedRA, CDISC controlled terminology and data governance, dictionary management for EDMS for Submission dossiers.

Quality Assurance:

• Experience in implementation and management for pharmaceutical/biologics/medical devices Quality Systems and Quality Risk Management Solutions.
• Direct experience with systems such as Veeva Vault, ETQ Reliance, Sparta TrackWise, OpenText, SharePoint, Master Control, Documentum D2, FirstDoc FirstPoint, NextDocs, UL ComplianceWire, and other quality information management or content management systems.
• Led requirements workshops: design, prototype, configure, and document content management/QMS data solutions.
• Handled and overseen day-to-day maintenance continuous improvement of Quality System IT Components, including but not necessarily limited to Deviation, CAPA, OOS, Complaint, and Change Control related technical solutions.
• Supported the preparation, coordination, and management of regulatory agency Preapproval or regular inspections from IT perspective.
• Worked closely with Business Stakeholders to ensure/coordinate appropriate and complete resolution of findings/non-compliant issues, quality investigations, etc. in a timely manner, including approval of corrective action and preventative action (CAPA) plans, as necessary.
• Participated or Conducted in internal audits (systems, processes, vendors, computer system validation)
• Provided IT expertise to investigation teams of quality management framework, controls, policies and procedures
• Experience with Quality System investigations and other concepts (Deviation, OOS, Issue Management, CAPA, Change Control, Audits, etc.).
• Must have working knowledge of FDA (21CFR 210, 211 & 820) and EU regulatory requirements.
• Provided quality oversight and compliance support to implement and validate electronic systems in accordance with the corporate computer system validation (CSV) procedures and requirements.

WHY JOIN US ?

We’re a network of entrepreneurial self-starters who contribute to something far bigger. We enable AstraZeneca to perform at its peak by delivering premier technology and data solutions.

We’re not afraid to take ownership and run with it. Empowered with unrivalled freedom. Put simply, it’s because we make a significant impact. Everything we do matters.

SO, WHAT’S NEXT?

Are you already envisioning yourself joining our team? Good, because we’d love to hear from you! Click the link to apply and we’ll be in touch as soon as we can.

WHERE CAN I FIND OUT MORE?

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

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.

Date Posted

06-Sep-2021

Closing Date

29-Sep-2021

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.