Medical Governance Expert

Job description

·  Job facts

Job summary

Medical Governance Expert is committed to continuous improvement and innovations, seeking out new ways of working, driving change in Medical Affairs area, while all relevant ethical, quality and regulatory standards are kept at high level. He/she demonstrates strong knowledge of key medical governance principles, critical, entrepreneurial, customer-focused mindset and a passion for delivering lasting value to customers.

Responsibilities

·  Enables, coaches and mentors individuals and teams new ways of working, combining understanding of key medical governance principles and agile approach
·  Foster innovation in all aspects of strategic and operational medical work by building the appropriate mindset, skills and competencies
·  Enables the development and sustainability of communities of practices, fosters collaboration and network behaviors
·  Contributes to creation of an environment of innovation and simplification - with primary focus on activities in Medical Affairs
·  Promotes the importance of full adherence of all Medical activities to all relevant mandatory external and internal regulations / requirements
·  Proactively seeks for the continuous improvement of all systems, ways of working, operational procedures - directly or indirectly associated with Medical Affairs activities
·  In collaboration with Medical Director and other functions within the Medical department and entire affiliate (e.g. People and Culture) lead and implement people development initiatives, in line with Roche competencies framework and medical competencies requirements
·  Build excellent cross-functional relationships and interactions between Medical and other affiliate teams, other Roche Affiliates and Global functions
·  Participate in strategic decisions and contribute/lead strategic projects for medical affairs team, fostering collaboration and alignment with regulatory, safety, clinical operations and other relevant teams (as applicable)
·  Facilitate relevant scientific and technical knowledge exchange between disease areas and create a holistic medical strategic approach, aligned with overall company direction and business strategy
·  Act as an ambassador, both internally and externally, for Roche s.r.o. and medical affairs organization
·  Cooperates with Medical Information System responsible for answers addressing the unsolicited questions from HCP and lay public
·  If needed, he/she is ready to overtake the tasks of Medical Partner
·  Deputizes for Medical Director if needed

Qualifications

·  University Medical Degree (M.D.) or/PharmDr. (Pharm Mgr.). MSc. / PhD. with therapy area experience may be considered as well, when medical signatory can be guaranteed.
·  At minimum 5 years of work experience in Medical Roles in innovative Pharma industry (e.g. Medical Advisor; Medical Manager; CRA; Clinical Study Manager; PhV roles; DRA roles; etc. );
·  Previous experience in Clinical practice and / or in Medical Governance is the advantage
·  Experience in the principles and techniques of study management, data analysis, interpretation, clinical relevance, medical writing and publications
·  Robust knowledge of ICH, GCP / GVP and regulations relevant for pharmaceutical medicine
·  Appreciates the diversity of working with cross functional teams
·  Previous experience in leading innovative projects highly desired
·  Knowledge of Czech and English
·  A customer centric mind-set
·  Driving license (Note: 20% of time spent in the field)

Please note the Saville competency assessment will be part of selection process.

Roche is an equal opportunity employer.
Medical Affairs, Medical Affairs > Medical Information/Scientific Affairs

·  Who we are

At Roche, 98,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an equal opportunity employer.