Clinical Writer - Basel - Top 3 Pharma
On behalf of one of the top 3 Pharma companies who are looking for a Domain Expert - R&D Documents, on a contract basis for at least 12 months to be based in Basel. This is a chance to be a part of one of the largest pharmaceutical companies in the world, where extensions are expected allowing you to gain exposure with a reputable name and ultimately build further value for your profile. This is a contract with guaranteed working hours of 40 hours per week.
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, and Clinical Safety Documents etc.
1. Collaborate with external vendor and NVS 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 mandatory document properties
2. Coordinate & oversee processes supporting extraction and migration activities by
o Driving Quality Control activities to ensure that the migration / migration automation 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 Novartis organization to align on migration requirements, 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
Call me Daniel Watson at NonStop Recruitment now for a confidential conversation. Contact me on D.Watson@nonstopconsulting.com or +41 435 080 817, please send your CV in word format OR if this does not sound like the opportunity for you, but you are a Contract professional within the pharmaceutical, medical device or biotech industry, please feel free to get in touch, to see other opportunities we may have within this field.
NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.