Medical Safety Writer - Data Migration

On behalf of one of the top 3 Pharma companies who are looking for a Domain Expert 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 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.

Major Accountabilities:
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
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 Developing decision flows for correct Artifact identification
o Coordinating and participating in Test Activities
3. Engage with stakeholders in the organization to align on migration require-ments, migration approach and missing or erroneous information in source system
4. Support Digital ambitions and gain insights on AI projects

Requirements:
* 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
* 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

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.