Location: Switzerland - St Gallen
Function: Research and Development
Company: Vifor Pharma
For this newly created role we are looking for a Records & Data Manager for our Regulatory Affairs (RA) department. You will be planning, developing and implementing systemic approaches to protect and manage regulatory documentation.
Your responsibilities will include:
- Develop and maintain policies, standards, and guidelines
- Act as owner and primary author for all RA (= regulatory affairs) records management related policies, SOPs and WIs
- Administer RA areas within corporate eDMS
- Provide training for staff in relevant Vifor processes, procedures and tools, including specific specific training and advice to RA staff for:
- OpenText Content Server (eDMS) application and associated tools
- TrackWise application and associated tools
- Standard IT applications such as Windows Explorer and Microsoft Office suite
- Lead selected records management initiatives (within RA or cross-functional)
- Chair relevant intra-departmental teams governing departmental systems document management and regulatory information management
- Conduct departmental records management audits and provide compliance/audit support
- Partner with department staff to resolve document discrepancies and to correct data issues in RA systems
- Provide records management KPI reporting
- Support QA in hosting and responding to external audits and inspections, and presenting information relative to RA
- Participate in cross-functional training groups (Trackwise, eDMS, eArchiving 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
We would like to welcome the following experience and skills for the role:
- Bachelor or Master degree required (e.g. MAS in Archival, Library and Information Science, MAS in Information Science)
- Previous employment in Records Management
- Expertise with Electronic Document Management Systems (eDMS) such as OpenText, Documentum, 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
- Excellent conversation level in English (oral & written)
You describe yourself as a person with excellent interpersonal, communicational, organizational and planning skills. You are able to work efficiently on your own with minimal guidance as well as in cross-functional teams.
Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions. The company’s goal is to be a global leader in iron deficiency, nephrology and cardio-renal therapies and strives to help patients around the world with severe and chronic diseases to lead better, healthier lives. Vifor Pharma Group has production sites in Switzerland and Portugal as well as a dynamic network of affiliates and partners offering broad market coverage all over the world. The company has an ever-growing global presence while at the same time remaining firmly rooted in its home market, Switzerland.
Vifor Pharma Group consists of Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, its joint company with Fresenius Medical Care; Relypsa; and OM Pharma.
For more information, please visit: http://www.viforpharma.com/en/about-vifor-pharma/who-we-are.