Associate Manager, Reg. Information Mgt, Process & System
Responsible for supporting the business and regulatory systems to support submissions such as INDs, IND amendments, BLAs, BLA supplements, MAAs, MAA variations and/or CTAs in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).
Strategizes, designs and implements new ways of working through the enablement of data to support the digital transformation of the Regulatory Operations business.
Works under minimal supervision. Requires little to no instruction on day-to day work and general direction on more complex tasks and projects Provides support and backup to management as needed
In this role, a typical day might include the following:
Supports the implementation of new RIM systems including the collection of business user requirements to enable features and functionality
Supports development of procedure documents, or best practices for RIM, both from a Regional and Global perspective
Develops and manages the xEVMPD and EU SPOR business processes, including the development of best practices for managing external data standards and vocabularies
Partners with I.T to investigate and explore disruptive technologies to enable automation opportunities
Understand and contribute to our end-to-end data workflows from data ingestion and transformation through to outputs
Supports system validation activities by developing and executing test scripts for systems that support RIM processes
Collaborates with the Regulatory Systems team and other key stakeholders with regards to data and process, including Regulatory Affairs, Clinical, Supply Chain and Discovery groups
Provides insight into new EU and Rest of World regulations, requirements, guidance, and/or specifications relevant to RIM
Supports strategy, implementation, and management of Regulatory Information Governance; supports related departmental and enterprise Data Governance programmes
Assists with audit and inspection activities including retrieval of Regulatory information
Assists data steward(s) with implementing data standards to facilitate data quality and governance within RIM systems Serves as a resource integrator – builds professional networks and identifies/connects resources to solve problems/issues and achieve goals. Regularly contributes actionable ideas in planning/design sessions
This role might be for you if:
Knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, eCTD, IDMP, UDI, etc).
Knowledge of pharmaceutical drug and device development process.
Experience in Regulatory Affairs/Operations/information.
Knowledge of Data Analytics/visualization tools such as PowerBI, Qlik or Tableau
Thorough knowledge and practical experience with RIM technologies (e.g. Veeva, Calyx, Cunesoft, LifeSphere)
Thorough knowledge and practical experience in global submissions
Thorough knowledge and practical experience with RIM technologies
Knowledge of scientific industry terminology
Strong knowledge of categorization and classifying information
Strong knowledge of relationships between key components of Regulatory Information
Experience managing technology projects (e.g. RIM, EDMS, tracking systems, etc.)
Ability to manage, and/or contribute to multiple ongoing projects simultaneously
Guides teams to solve significant issues, including clarifying, interpreting and analyzing complex information and developing recommendations for management
Strong knowledge of technical writing is required Experience in SOP writing is preferred Change management experience preferred Ability to engage and influence a variety of stakeholders at all organizational levels required
Can work independently, ability to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has excellent written and verbal communication skills.
Working knowledge of eCTD and Non-eCTD formats, awareness of submission validation and viewing tools, XML, Microsoft Office suite, and Adobe Acrobat are required.
Working knowledge of technical writing is preferred.
Possess courage, energy and drive, strong operating skills, strong personal and interpersonal skills, strong critical thinking, and strong strategic skill