Business Process Document Manager

AstraZeneca • Durham, NC

2d • Hybrid

About The Position

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. 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 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’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention. Introduction to Role: Clinical Operations with in the Biopharma business unit is accountable for the delivery of clinical studies. Process, Quality & Business Capability serve across AstraZeneca R&D (Research & Development) , providing data-driven insights to inspection readiness, regulatory compliance, processes , and learning. Listening to AZ and external Voice of the Customers, aligning to AZ goals , and removing the worry about our procedures, CAPAs (Corrective and Preventive Actions) , Quality Issues whilst implementing major change initiatives. Business Process Management & Optimisation d eliver s process excellence through a strong core capability partnering cross functionally to drive efficient continuous process improvements using lean methodology & data insight. Resulting in optimised clinical study processes fit for the future . The Business Process Document Manage r is a member of the Business Process Management and Optimisation (BPMO) Document Managers team , and is responsible for control, security, accessibility , development and timel y delivery of process related documents for the clinical business processes owned by BPMO. On “Business as Usual” (BAU) the Business Process Document Manager will support assigned business sub- process es and as such will work closely with the Business Process Owners accountable for those sub-processes in day to day maintenance of assigned area, including but not limited to authoring of documents, trainings, managing reviews and communication , applying lean methodologies and seeking for continuous improvement . As part of this role Business Process Document Manager will be responsible for managing process “toolkits” and the maintenance and upkeep of the toolkit platform and contents as well as all communications regarding process updates supporting their business process areas. It will include work ing closely with Document Management System team to ensure that the processes/standards is adhered to and provide feedback to the Quality team following issue analysis arising from the BPMO process management. Business Process Document Manager will work on developing and applying improvements within process documents managed by BPMO applying lean methodologies and technical features of MS Office package as well as looking for improvements for central templates owned by R&D and applied by BPMO. Role will act as a champion for process and document management excellence , and role model adherence to the business process framework. As the need arises, will act as a mentor for other BPMO colleagues in document management related areas . As required, will work closely with IT team to facilitate the smooth operation of the document management system . As part of this role additional responsibility can be assigned in relation to operational maintenance and administration of BPMO used tools in process management (ticketing system for process questions, R&D repository for process toolkits) .

Requirements

• Bachelor’ s Degree in an appropriate discipl in e or equivalent experience
• Experience in document management and document management systems
• Good knowledge of ICH GCP, understanding of clinical trials
• Proven ability of working with multiple documents on global level (creation, revision, maintenance) up to the standards
• Change management
• Demonstrated skills to deliver to time, cost , and quality
• Proven ability being an end user of a process
• Proven ability in communication both orally and in writing on a global level
• Proven ability in presentation skills
• Demonstrated ability in knowledge transfe r (mentoring)
• Collaboration and problem solving skills
• Experience in working successfully and collaboratively within own team as well as cross-functionally

Nice To Haves

• Experience within a pharmaceutical or clinical background
• E xperience as a process owner in clinical process management
• K nowledge of business process management tools and lean methodologies
• Experience of utilizing standard process improvement methodologies ( e .g ., Lean Six Sigma) to identify root causes of process issues and identify areas of process improvement
• Demonstrated ability see change as an opportunity to improve performance and add value to the business

Responsibilities

• Develop and maintain process related documentation (mandatory, best practice and training) within an assigned sub- p rocess es as per agreement with Business Process Owner
• Maintain assigned process toolkit(s) and relevant tools (for example MS teams channels)
• Manage process related question s in relevant process ticketing system
• Participate and e ngage in process network or appropriate forums to encourage best practise s
• Participate and support improvement projects
• Drive adherence to managing procedural documents process in daily work
• Manage continuous improvement and change
• Facilitate sharing of good practice and learning within function and cross functionally
• Identify issues and risks, escalate as through appropriate governance forums
• Manage links with related processes

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level