Electronic Document Specialist
il y a 1 jour
Study documentation (study protocols, Bioanalytical methods, reports, phase reports, PK appendices...
Check and revision of technical styles and formats according to referential (Regulatory Affairs Template Specification Guide )
Upload of the documentation in Vault RIM DM (Global Nonclinical Nomenclature and Classification)
Numerous and “miscellaneous” interactions with our partners (ie, document authors): feedback on the revisions we brought to the document’s structure, or preliminary pages, warning for any discrepancy or gap with respect to the expected standard
Follow up of documents life cycle (from creation to approval) (As per the processes defined in TMED for BCB and PKDM, respectively.
Regulatory documentation
Submission to the Authorities (FDA, EMA)
Check / correct the PDF formats of the TMED reports and literature submitted in Module 5 so that they are compliant for electronic submission.
Complete SCP (Submission Content Plan);
Provide extract to Regulatory so that the expected “nodes” are created in the SCP;
Interactions avec PK Lead, Regulatory in charge of submission etc.
**Submission to the public (for EMA agency**: P70 or Health Canada: PRCI)
Creation of Vault binder, report upload with previous docbase metadata
Verification of conformity of TMED reports submitted in Module 5
(Feedback to the Medical Writer for escalation to the Vendor in charge of anonymization)
Interactions with Medical Writer and Clinical EDS.
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