- Archive Records (classification, indexing, digital record creation)
- Retain Records (physical and digital records storage, retrieval and retention
- Disposition Records (records destruction, transfer and retention extension)
- Facilitate workflows to create, revise and/or retire effective GMP Documents
- Facilitate translation of GMP Documents as needed with external vendor
- Provide support to business partners on best practices in document and records management.
- Assist in the development of content and knowledge classification taxonomies to facilitate information capture
- Identify and classify knowledge and content according to characteristics such as security level, process, function and metadata
- Develop, document and maintain standards and best practices for knowledge and content
- Assist in system and content access rights and revision control to ensure security of system and integrity of master documents/content. Support other Corporate Quality Initiatives as needed.
- Work with business leaders and stakeholders to identify areas of opportunity and gaps.
- Develop and facilitate the use and improvement of common knowledge and content management processes and approaches across the organization.
- Assist with monitoring and reporting progress on implementations.
- Assist in the development and communication of capability performance metrics.
- Monitor the effectiveness, maintenance and use of the IT tools and systems (as they apply to KM/CM).
- Approximately, 4-6 years of experience in pharmaceutical or biotech manufacturing environment is recommended. Requires prior experience with data/information/knowledge/content management and project management. Previous experience with business process management, enterprise system management and cGMP Quality Systems Management preferred.
- A Bachelor's of Arts/Science Degree and 3-5 years relevant experience.
- Clear understanding of business situations and processes.
- Good working knowledge of organizational and business strategy.
- Creative and self-motivated with strong problem-solving skills (thinks outside the box).
- Strong facilitator, change agent, and communicator (a good consultant)
- Able to think strategically in terms of culture, behavior, business processes, and tools.
- Good appreciation of customer needs at both the operational and strategic level.
- Strong project management oversight with "hands on" skills as needed.
- Expertise in MS Word and the use of macros.
- Understanding of Information Technology with proficiency in Microsoft Office (mastery in MS Word and the use of macros), master and metadata management, Electronic Document Management Systems, Content Management Systems, and Business Process Management Systems.
- Experience implementing and/or using Veeva Quality Docs is a plus.
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Knowledge and Content Management Associate III - Luterbach, Schweiz - Biogen
Beschreibung
About This Role
The Corporate Quality Knowledge and Content Management team is responsible for developing and delivering the strategies, methods and tools used to identify, capture, manage, store, and deliver all information assets (knowledge, content, and records) related to organizational processes within Pharmaceutical Operations and Technology (PO&T).
The Knowledge and Content Management Associate will promote knowledge sharing and effective content management throughout the organization's operational business processes and systems. The scope for this position will deal mainly with process and compliance related content (specifically documentation including governing policies, process documents, and other similar GMP documents) currently residing in the electronic document management system as well as managing GXP records throughout their lifecycle. This role will also include facilitating a transition to a process-centric operating model, aligning process content with the appropriate business process. The primary responsibilities include: support in the implementation and enhancement of core Knowledge Management (KM) and Content Management (CM) approaches and standards, monitoring and reporting progress of KM and CM initiatives, management and maintenance of KM and CM master and metadata (keeping enterprise metadata aligned with source, organizing content, ensuring appropriate ownership and oversight for content), protecting, indexing, classifying and archiving GXP Records, digitally preserving vital records, records lifecycle management, and managing the process for translating GMP content needed in multiple languages.
What You'll Do
Support the enterprise Document and Records Management Programs.
Provide tactical support to efforts related to management of knowledge and content (steward established processes and tools).
Participate in the design, implementation, and enhancement of core KM and CM approaches used to identify, capture, manage, store and deliver information assets.
Monitor KM/CM Capabilities.
Support other Corporate Quality Initiatives as needed.
Who You Are
You have solid experience in pharmaceutical or biotech manufacturing, proficient in data and project management, and knowledgeable in cGMP Quality Systems. You understand business strategies, and are a creative problem-solver, effective communicator, and skilled in MS Office, particularly MS Word macros and metadata management.
Qualifications
Additional Information
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. to learn more about our DE&I efforts.
