Full-Time Sr. Associate, Regulatory Operations Technology
The Senior Associate Regulatory Operations Technology is responsible for effective support, operation, and maintenance of systems and software and related infrastructure. This individual participates in technical research and development to enable continuing innovation within the infrastructure. This individual ensures that software systems and related procedures adhere to organizational values, while enabling staff.
This individual will assist project teams with technical issues in the Initiation and Planning phases of our standard Project Management Methodology. These activities include the definition of needs, benefits, and technical strategy; research & development within the project life-cycle; technical analysis and design; and support of operations staff in executing, testing and rolling-out the solutions. Participation on projects is focused on smoothing the transition of projects from development staff to production staff by performing operations activities within the project life-cycle.
Under direct supervision, assists in the installation company’s systems. Correct software failures by working with appropriate vendors and site contacts during and outside business hours as necessary. Performs own work and provides assistance to others as directed. Skills are typically acquired through completion of an undergraduate degree in an IT related discipline or equivalent related work experience and 2 years of experience in a corporate IT or Regulatory Operations environment.
In addition to supporting software activities, will also:
· Support the electronic document management system (EDMS) team and system users with migration and archive of documents into the system as required.
· Answer inquiries from employees, consultants and contractors regarding the functionality of the EDMS system.
· Configure / add new users to the system; including training, functional testing and coaching to ensure successful system usage.
· Partner with Head of Reg Ops and IT to plan, execute, and support IT systems for Specialty Brands Pharma products
· Support the upgrade and configuration of system software that supports IS infrastructure applications per project or operational needs.
· Proactively identifying RA data/ document management strategies and needs (Business Development and Mergers and Acquisitions) ensuring regulatory documents are properly received, stored, tracked and retrievable according to appropriate industry standards and regulatory guidelines covering but not limited to internal SOPs, WIs, ICH guidelines, HA regulations and legal standards for document retention.
· Perform daily system monitoring, verifying the integrity and availability of all hardware, server resources, systems and key processes, reviewing system and application logs, and verifying completion of scheduled jobs such as backups.
· Author or revise work instructions, user manuals or other system required documentation.
· Create, update, and deactivate user accounts per request.
· Perform regulatory file archival (paper and electronic) as necessary.
· Maintain operational, configuration, or other procedures.
· Provide on-call service to users after regular duty hours and extended support during periods of increased system usage (including weekends).
· Perform ongoing performance tuning and resource optimization as required.
· Provide phone, over the shoulder, and online support to a wide variety of clients.
· Conduct document and process change reviews for impacts on internal system standards and process.
· Contribute to and maintain system standards.
· Research and recommend innovative, and where possible automated approaches for system administration tasks. Identify approaches that leverage our resources and provide economies of scale.
· Bachelor (4-year) College degree or at least three years of regulatory system administration work experience and 2 years of experience in a corporate IT or Regulatory Operations environment.
· EDMS experience in Veeva and Documentum.
· Experience in regulatory systems (RIM, eCTD Publishing, EDMS, Labeling)
· Expert proficiency in MS Office: Word, Excel, PowerPoint and SharePoint.
· Ability to communicate effectively in English both verbally and in writing.
· Ability to prioritize work and support requests.
· Experience in Adobe Acrobat and related scanning applications to convert paper to electronic files
· Experience working in a pharmaceutical drug development company
· Experience with regulatory requirements (ICH e3, eCTD and 21 CFR Part 11)
· Troubleshooting and analytical thinking skills
· Comfortable leading training sessions or presenting to a large group of users.
· Monitor and resolve or escalate system issues
· Learning and working with new technologies on a constant basis
· Flexibility in work hours to cover a rotating schedule including early evenings and weekends
· Excellent presentation, written and verbal communication skills
How to ApplyIf interested and qualified, please clink on the below link to apply: https://mallinckrodt.wd5.myworkdayjobs.com/MallinckrodtCareers/job/US-Specialty-Brand-Headquarters---USA501/Senior-Associate-Regulatory-Operations-Technology_JR000009666
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