no-458

Domain Expert – R&D Documents / no-458

Location
CH-Basel
Start
asap
End
13.09.2021
Workload
100 %
All-in / Hour
please ask us
Total Hours
1900
Deadline
Deadline
18.09.20, 10 am.
no-458

Domain Expert – R&D Documents / no-458

Location
CH-Basel
Workload
100 %

Start

asap

End

13.09.2021

DEADLINE

Deadline
18.09.20, 10 am.

  • CH-Basel
  • no-458CH-Baselasap13.09.2021100 % 1900please ask usDeadline
    18.09.20, 10 am.

For our customer located in Basel St. Johann/Switzerland we are currently looking for a: Domain Expert – R&D Documents (m/f/d)

 

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.

Tasks & Responsibilities

  • 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 man-datory document properties
  • Coordinate & oversee processes supporting extraction and migration activities by
    • 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
    • Collaborate closely with CDGM organisation and business process owners to ensure alignment of migration activities with parallel system and/or process updates.
  • Engage with stakeholders in the organization to align on migration require-ments, migration approach and missing or erroneous information in source system
  • Support Digital ambitions and gain insights on AI projects

Must Haves

    • 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

Did we catch your interest? 

The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).

Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.

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Files must be less than 5 MB.
Allowed file types: txt rtf pdf doc docx.
If not - no problem - we'll organize one.
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