Domain Expert - R&D Documents
Posted on Sep 4, 2020 by Michael Bailey Associates - UK Contracts
Job Titel: Domain Expert - R&D Documents
Senior Domain Expert for Clinical R&D Documents to support Source-to-Target Migrations of Clinical Documents. This resource will lead Migration Data Preparation activities and assist to determine all properties and attributes for Clinical Submission Documents such as Clinical Study Reports, Module 2 Documents, Clinical Safety Documents etc.
1. Collaborate with external vendor and client internal functions to
o build, expand and automate the migration approach for R&D (Clinical Submission, Safety) documents from Source to Target System
o build, expand and automate the Attribute Extraction Approach to determine man-datory document properties
2. Coordinate & oversee processes supporting extraction and migration activities by
o Driving Quality Control activities to ensure that the migration/migration automa-tion process is producing high quality outputs
o Coordinating and participating in Test Activities
3. Collaborate closely with CDGM organisation and business process owners to ensure alignment of migration activities with parallel system and/or process updates.
4. Engage with stakeholders in the client organization to align on migration require-ments, migration approach and missing or erroneous information in source system
5. Support Novartis Digital ambitions and gain insights on AI projects
. Minimum Bachelor's degree in life science/healthcare or equivalent
. Fluent English (oral and written), German of advantage
. Minimum 10+ years experience in LifeScience Industry
. Extensive experience with usage of clinical document management systems
. Working knowledge in a function exposed to R&D Documents Management (Medical Writing, Submission Management, Safety)
. Experience with coordinating deliverables from 3rd party vendors
. Knowledge of ICH GCP, 21 CFR part11
. Experience with Documentum based D2LS system is a plus.
. Experience with Document Migration Projects is a plus
. Experience working as Business Analyst is a plus
Michael Bailey International is acting as an Employment Business in relation to this vacancy.