The scoreboard, honestly: the hard targets, how often each one is actually looked at,
and the quiet human signals that never make it onto a dashboard.
Submission Data Entry Accuracy
The percentage of data points you enter into our Regulatory Information Management (RIM) system that are correct and match the source documents.
Target · 99.5% accuracy (meaning very few errors)If you enter 200 data points for a submission, we'd expect no more than 1 error. Catching a typo in a product name or a wrong date before it goes out is a win.
On-Time Document Gathering
How often you get the required documents from internal teams by the agreed deadline, especially when supporting a submission.
Target · 95% of assigned document requests completed on timeIf you're asked to collect 10 documents for a submission by Friday, getting 9 of them in by then, despite chasing, is good. Getting all 10 is excellent.
Administrative eCTD Validation Errors
The number of basic administrative errors (like incorrect file naming or missing metadata) in the sections of eCTD dossiers you've helped to prepare or publish.
Target · Less than 1% of documents show administrative errorsYou've helped prepare 100 documents for a module, and only one had a wrong bookmark. That's what we're aiming for. Zero is always the goal, of course!
Commitment Tracking Update Timeliness
How quickly you update the system when a regulatory commitment (a promise we've made to a Health Authority) is completed or changes status.
Target · All updates within 24 hours of receiving informationR&D tells you a study promised to the FDA is finished. You update the tracker the same day. This helps us stay on top of our obligations.
Adherence to Standard Operating Procedures (SOPs)
How consistently you follow our established processes and guidelines for document management, data entry, and submission preparation.
- Evidence: Your manager rarely needs to correct your process steps. You can explain the 'why' behind a procedure. You ask clarifying questions when a process isn't clear, rather than guessing.
Learning and Application of Regulatory Knowledge
Your proactive effort to learn about regulatory requirements and systems, and how well you apply that new knowledge to your daily tasks.
- Evidence: You're asking thoughtful questions about 'why' we do things a certain way, not just 'how'. You pick up new system functionalities quickly. You can explain basic CTD structure after a few months.
Proactive Problem Identification
Your ability to spot potential issues or discrepancies in documents or data before they become bigger problems, and then escalate them appropriately.
- Evidence: You flag a document that looks like an old version. You notice a date mismatch between two records. You don't just ignore something that 'feels' wrong, you bring it up.
Team Collaboration and Support
How well you work with your immediate team, offering support when needed and responding positively to feedback and requests.
- Evidence: You're quick to offer help if a colleague is swamped. You take feedback constructively. You communicate clearly about your progress and any blockers you hit.