For our client, a leading international pharmaceutical company with headquarters in Basel, we are looking or a motivated personality in the function of
Domain Expert - R&D Documents (m/f) 80-100%
Senior Domain Expert for Clinical R&D Documents to support Source-to-Target Migrations of Clinical Documents. This resource will support the Migration Data Preparation activities and assist to determine all properties and attributes for Clinical Submission Documents such as Clinical Study Reports, Submissions, CTD modules and appendices, Clinical Safety Documents including Submission and reporting etc.
Act as Subject Matter expert the key role will be to assign correct document Artifacts and document Attributes (e.g. Submission date, eCTD section) for Submission relevant Clinical R&D documents (focus GCP)
1. Collaborate with external vendor and NVS internal functions to
- build, expand and automate the migration approach for R&D (Clinical Submission, Safety) documents from Source to Target System
- build, expand and automate the Attribute Extraction Approach to determine mandatory document properties
2. Coordinate & oversee processes supporting extraction and migration activities by
- Driving Quality Control activities to ensure that the migration / migration automation process is producing high quality outputs
- Developing decision flows for correct Artifact identification
- Coordinating and participating in Test Activities
3. Engage with stakeholders in the Novartis organization to align on migration requirements, migration approach and missing or erroneous information in source system
4. 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 experiences in Life Science Industry
- Minimum 5 years in a Clinical development, Pharmacovigilance or Drug safety position
- Extensive experience with usage of clinical document management systems
- Expertise in either Clinical (Phase I-IV) Regulatory documentation, Pharmacovigilance documentation or GCP medical writing
- 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
Start Date: 1. November 2020
End Date: 31. October 2021
Please apply online. For further information about the position, please contact your Kelly recruiter, Mrs Heidi Arbogast (+41 61 270 80 44).
We connect people to jobs in ways that enrich lives. Kelly Services® is a leading global provider of human resources solutions, operating in over 40 countries. Together with its subsidiaries, Kelly offers a wide range of outsourcing and consulting services; temporary, permanent and management positions as well as flexible forms of employment at all hierarchy levels. Kelly Services (Schweiz) AG has been present in Switzerland since 1979 and counts more than 200 employees in over 40 Talent Offices and Centers. Kelly Services Switzerland is acting as an Employment Business in relation to this vacancy.