Electronic Document Management System Manager (EDMS)

Electronic Document Management System Manager (EDMS)

My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their regulatory team in Switzerland, Vaud Canton.

 

Due to this growth my client is looking for an Electronic Document Management System Manager to join them on a permanent contract.

 

Responsibilities:

 

• Responsible of the Global Regulatory EDMS (Electronic Document Management System)
• Manage Regulatory requirements and define business processes
• Coordinate with IT support and/or service providers as needed

• Responsible to maintain Global Regulatory EDMS in a compliant and validated state
• Maintain/develop the application and related processes
• Ensures maintenance and business support of the system
• Interface with key users from R&D departments (Regulatory, Clinical, Pre-Clinical …)
• Interface with IT for technical support
• Coordinate/Implement training program for end users
• Lead/Organize Computer System Validation (CSV) activities
• Lead User Teams and Governance Board
• Maintain SOPs, instructions related to EDMS.
• Propose/implement process improvements

• Propose/participate in steps required to maintain regulatory compliance

 

Your profile:

 

· Degree in IT or Scientific or equivalent

· Minimum 8 years experience in Pharmaceutical Industry

· Minimum 5 years in similar role in IT, Clinical or Regulatory departments

· Strong experience with EDMS (Documentum/D2 preferred)

· Experience with Computer system validation (CSV)

 

 

Noemie Oliva noliva@axepta.com

More than 7 years experience as a Specialist Pharmaceutical and Medical Device recruiter and headhunter recruiting in Switzerland and France for the provision of Pharma and Medical Device staff. Specialties: Pro-active Search, Targeted Advertising, Professionalism, Networking, Permanent Recruitment, Freelance Recruitment, Hard to fill vacancies, Multiple vacancies, Urgent Vacancies If you would like to have a confidential discussion regarding your search for staff or your search for a new position please feel free to contact me directly at noliva@axepta.com