Regulatory Affairs Records and Data Manager job in Zürich, Switzerland

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: Operations

Location: Switzerland

This vacancy has now expired. Please see similar roles below...

An exciting opportunity has arisen for a Regulatory Affairs Records and Data Manager at a pharmaceutical company in Zurich. The bright individual will be able to step up and grow organically within the company which is perfect for an individual who is looking for a career development.

Job Responsibilities

Act as owner and primary author for all Global Regulatory Affairs (GRA) records management related policies, SOPs and work instructions
Provide training for staff in relevant Vifor processes, procedures and tools, including specific training and advice to GRA staff for OpenText Content Server (eDMS) application and associated tools
Lead selected records management initiatives (within GRA or cross-functional)
Chair relevant intra-departmental teams governing departmental systems document management and regulatory information management
Conducting departmental records management audits and providing compliance/audit support
Partner with department staff to resolve document discrepancies and to correct data issues in GRA systems
Provide records management KPI reporting
Support QA in hosting and responding to external audits and inspections, and presenting information relative to GRA
Participate in cross-functional training groups (eDMS, RIMS, e-Archiving initiative, interdepartmental authoring processes)
Provide regulatory input into the development and maintenance of global records retention schedules to ensure corporate policies and standards are consistent with Swiss, EU and global regulatory requirements

Skills and Requirements

Bachelor's degree or equivalent required
Previous employment in Records Management
Expertise with Electronic Document Management Systems (eDMS) such as OpenText, Documentum, MS SharePoint, etc.
Minimum 5 years relevant work experience in a regulated industry (e.g. pharmaceuticals, medical devices, insurance, financial services, transportation or government administration)
Experience with analysis of data, file structures, format transformations, and data mapping
Expertise with common standards such as ISO 15489, ISO 23081, MOREQ2010 or Swiss, US or EU Member State federal standards

To Apply

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Alex Czuprynski, alex@proclinical.com or upload your CV on our website - www.proclinical.com/send-cv

A full job description is available on request.

#LI-AC1

#Regulatory

Salary

Highly Competitive Salary

Location:

Philadelphia, USA

Proclinical Staffing is seeking an Associate Director of Regulatory Affairs to join a top medical program.

Natalie Magola

Apply

Senior Director, Regulatory Affairs - REMOTE

Salary

Up to US$290000 per annum + Highly Competitive Salary

Location:

Boston, USA

Proclinical Staffing is seeking a Senior Director, Regulatory Affairs to join a leading health information technology and clinical research organization.