COMPLETE Medical Compliance Lead - EMEA, CH, Kanton Zurich, Opfikon, CSL Vifor

CSL Vifor is actively looking for a Medical Compliance Lead based in Glattbrugg and that will report to the Head Global Medical Affairs. Your role and responsibilities will be the following, but not limited to :

Responsibilities:

• Driving Medical Compliance at HQ, including leading or contributing to cross-functional projects

• Key contact for affiliates & regions, Global Medical Affairs (GMA) and other HQ functions regarding Medical Compliance topics

• GMA training (LMS curricula), procedural document (PD) and CAPA management

• Oversight of Patient Support and Managed Access Programs

• Process Owner of electronic system to document approval of promotional & non-promotional materials (Veeva PromoMats)

• Representing GMA in audits & inspections

• Member of GMA Leadership Team (GMALT) and Global Compliance Committee CMRS (GCC)

Tasks:

• Regular communication about cross-functional Medical Compliance topics to Local/ Regional Medical Directors and compliance contacts

• Ensures GMA LMS curricula represent training needs, user information is up-to-date and GMA staff completes training in LMS

• Ensures deviation management for GMA and timely CAPA implementation

• Represents GMA in audit & inspection preparation, execution and follow-up

• Ensures GMA PDs and local Medical procedural document templates are developed and up-to-date

• Leads the review and approval of Managed Access Programs and ensures global oversight of Patient Support Programs

Minimum Requirements

• Scientific (Ph.D., Pharm. D.) or medical education (M.D.)

• Minimum 5 years of experience in pharmaceutical industry

• Experience in affiliate/ regional and Global Medical Affairs, incl. responsibilities for Medical Compliance

• Experience with health care industry compliance tasks

• Leadership experience from previous positions

• Professional level in English, both in oral and in written communications

• Knowledge of commercialization and business practices

• Knowledge of Regulatory Affairs, Drug Safety, Clinical Research and Quality Management

Preferred Requirements

• 8 years industry experience including Medical Affairs/ Medical Compliance at affiliate/ region as well as at global level

• 4 years of experience in a major pharmaceutical company 

• Experience with pharmacovigilance, clinical research and scientific publication processes

• Experience with managed access programs

• Successful leadership of cross-functional projects and teams

• Experience of managing individuals and teams

About CSL Vifor

CSL Vifor aims to become the global leader in iron deficiency and nephrology.

The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care.

For more information, please visit viforpharma.com

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