We are seeking a Medical Compliance Manager who will be based at our operational headquarters in Zurich. Driving medical compliance, including optimizing the review and approval of promotional and non-promotional materials at Vifor Pharma (i.e. procedures and electronic systems), leading or contributing to cross-functional compliance projects, and being a key contact for affiliates and regions and other functions regarding medical compliance topics. Reporting directly to the Medical Compliance & Operations Lead, your tasks and responsibilities will include, but not be limited to, the following:
- As a system administrator, ensure optimal use of VeeVa Vault PromoMats at Vifor Pharma, including User management & training
- Responding to enquiries, requests and suggestions sent by PromoMats Key Contacts (local & HQ), incl. evaluation and ensuring implementation of configuration changes
- Ensure Medical procedures are developed and up-to-date
- Manage Medical Affairs deviations and ensure timely Corrective and Preventive Actions (CAPA) implementation
- Regular communication about cross-functional Medical Compliance topics to Local/ Regional Medical Directors and compliance contacts
- Represents Medical Affairs in audit and inspection preparation, execution and follow-up
- Leads the review and approval of Managed Access Programs and ensures oversight of Patient Support Programs
- Ensures Medical Affairs Compliance training is provided and documented in Learning Management System (LMS)
The ideal candidate is bringing a higher education, in addition to the following experience:
- Minimum 6 years of experience in pharmaceutical industry, majority in Medical Affairs / Medical Compliance at affiliate as well as at headquarters level
- Experience with management of VeeVa Vault PromoMats and/ or ZINC Maps, e.g. as a Key User or as business and/ or system administrator
- Experience with health care industry compliance tasks
- Ability to translate compliance requirements (laws and regulations) in simple processes with optimal resource utilisation
- Knowledge of Regulatory Affairs, Pharmacovigilance, Clinical Research and Quality Management
- Successful leadership of and effective work with cross-functional projects and teams (Medical Affairs, Quality Management, Legal/ Compliance, etc.)
- Strong procedural document writing skills
- Fluent in English, both in oral and in written communication. German, French, Spanish are a plus
You are structured, well-organised and attentive to details. You have very good stakeholder management skills and communications skills at all levels. You have a strong customer orientation with the ability to continuously expand knowledge. You act as a role model for others in line with Vifor Pharma values.
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 companys 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