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We are currently looking for an Associate Manager GRA Clinical Support to join our Regulatory Affairs team. This role reports directly to the Head Regulatory Affairs Clinical Support and is planned to be based in Zurich. Your responsibilities will include:
Support the design of clinical studies from a regulatory affairs point of view
Support the compilation, submission and maintenance of INDs/CTAs for clinical development programs in alignment with GRA CST members.
Audit GRA components of TMFs, clinical activity related records in Trackwise, and support CMRS QA audits and inspections related to clinical topics.
Maintain appropriate regulatory archive structures capturing all clinical regulatory documents supporting CTAs and related correspondence with CAs on an ongoing basis to ensure easy and quick access to all documents.
Act as GRA Archivist and interface to QA for TMF related materials
Coordinate vendor support arrangements for clinical-related medical writing for the GRA department
Ensure trial registrations and results data are posted online to the required clinical trial portals and databases (i.e. EudraCT, clinicaltrialregister.eu, clinicaltrials.gov, etc.) either directly or in coordination with external vendors.
The successful candidate is willing to work effectively with a wide variety of personnel across diverse teams and functions internally as well as external partners. In addition, you will bring the following profile:
University degree, preferably in pharmaceutical or health related field
2 - 8 years’ experience in clinical development or regulatory affairs in the pharmaceutical industry (prescription drugs)
Previous exposure to clinical studies design
Proven, first-hand experience of working in a fast paced team environment
Experience in working in a multinational regulatory affairs environment within the pharmaceutical industry
Familiarity with the global regulatory environment and GCP regulations
Familiarity with CTA/IND processes to support multinational clinical trials
Good computer skills, including proficiency with MS Office (including Word and PowerPoint)
Experience with eDMS, records management, or catalogue database systems
Familiarity with regulatory information management (RIM) systems or clinical trial management systems (CTMS)
Professional in English (oral and in writing) requiredProficiency in German or French an advantage
You describe yourself as a good communicator, with strong teamwork skills as well as good organization and negotiation abilities. You demonstrate accuracy and attention to details with a focus on quality and regulatory requirements. Finally, you are able to cope with stress and demonstrate discretion in the handling of confidential information
Internal Number: 2049
About Vifor Pharma
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 .