Regional Medical Director Europe (m/f)

SANDOZ
Division SANDOZ
Geschäftseinheit BioPharma SZ
Standort Holzkirchen (near Munich)
Funktionsbereich Research & Development
Art der Stelle Vollzeit
Anstellungsverhältnis Regular
StellenID 246048BR


Stellenbeschreibung

Your responsibilities:

Provide medical oversight throughout Europe

Develop, implement and execute the Europe Medical Affairs Plan for registered and in development biosimilars

Develop the medical part of the Global Brand Plans to represent Europe in collaboration with the respective Medical Directors (Global & Regional) and other internal stakeholders

Development and implementation of medical education for external stakeholders

Lead medical pre- and launch activities such as educational activities, advisory boards, and medical presentations in countries to key stakeholders of the region

Development and implementation/ support of regional key medical events such as symposia/ standalone meetings in close collaboration with key stakeholders from the countries/ region/ global

Training on product clinical evidence to affiliates/ key stakeholders

Support of clinical trials, including global studies of GMA (i.e. NIS, Registries etc.) in the region if needed, in close collaboration with the global clinical development

Planning, coordination, and presentations at global, regional and supporting national Advisory Boards

Interaction with external medical and scientific leaders and assist with education of product advocates

Development and implementation of key international congress symposia in collaboration with relevant global or regional/local functions

Interaction with key medical societies, e.g. to represent Sandoz biosimilars in medical guidelines

Medical approval and implementation of grants for scientific projects in Europe
Coordination of interactions with regulatory stakeholders in close cross-functional alignment with different functions in the global organization

Input into regulatory authority interactions, for example RMPs, PSURs, defending risk/benefit

Input into early phase, clinical development or market access for relevant products

Analysis and planning of resource needs in Medical Affairs within the Region
Represent medical affairs at country business unit reviews, providing strategic direction from medical perspective

Publication planning, delivery, and dissemination in close collaboration with Head Clinical/Medical Communication and global Medical Directors

Support countries with respect to compliance by continually assessing what is required at country level including audits, CAPAs, trouble shooting, setting guidelines for medical activities

Evaluate and advice on appropriate affiliate resourcing, skills and capabilities are in place to support CO, regional and global medical affairs activities, global research and development activities, and business support



Research & Development


Mindestanforderungen

Your requirements:

Advanced degree in related discipline, MD, PhD

At least 5-8 years’ experience in the Pharmaceutical Industry with experience of medical affairs, clinical trial management, and general management

Experience with Biosimilars of advantage

Experience in a predominantly international setting is desirable

Leadership skills at the cross functional team level and can work within global environment are expected

Networking and relationship building skills are well established

Ability to manage most aspects of the GMA responsibilities expected in a global organization and at various stages of development and marketing of product

Experience with clinical trials and post-marketing studies is highly desirable

Strong presentation skills

Experience with regulatory authorities is highly desirable

Ability to critically review current literature, providing relevance to our products and markets

Planning and organizational ability

Fluent in English



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