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Regulatory Writer - Basel - Top 3

Employer
NonStop Consulting
Location
Basel
Salary
Negotiable
Closing date
Oct 29, 2020

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Sector
Science, Life Sciences, Anatomy/Physiology
Contract Type
Contract/Freelance
Hours
Full Time
Organization Type
Corporate

Job Details

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.

Job purpose:
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.

Major Accountabilities:
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

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
* 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.

Company

Our Consultants are trained to deliver an exceptional standard of recruitment services to clients across the life sciences, chemical, care, educations, technical, digital and finance industries. 

Our clients – and bottom line profits - tell us that we do a great many things very well. Complacency, however, is the last word you would associate with us. We work incredibly hard to deliver better and better results, based on stronger and stronger service delivery.  Which is why we believe the best is yet to come – for us, our clients and for the people who have what it takes to join us on the journey.

The result? We’re expanding (in the UK and across Europe and even to Boston, US) and continue to post impressive performances in all our niche sectors. 

Company info
Website

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