Purpose of the position – for an innovative, international pharmaceutical company
- Coordinate and manage medical affairs department within country – medical advisors, MSLs
- Scientific support to documentation related to products and therapeutic areas where is company involved
- Coordinate in collaboration with Global Research and Development department the local performance of clinical trials.
- Responsibility for regulatory affairs and pharmacovigilance
- Directs all aspects of organisation´s medical policies, standards and programmes and ensures all medical activities are compliant with all applicable regulations
- As cluster brand medical lead one key product supervisory medical support on CE Cluster level
Clinical Trials
To facilitate and coordinate the participation of Czech Republic in clinical trials developed by R&D / GMA
To advise and coordinate local clinical trials, both Company-sponsored and Investigator-sponsored studies
To deliver feasibility of CT and propose clinical centers for participation to R&D / GMA & EA Med HQ international studie
Business Support
To ensure development and maintenance of a medical and scientific information service in the key areas to provide support to Health Care Professionals
To manage and mentor medical advisors and MSLs and conduct their performance appraisal for medical affairs and lead medical organisation to deliver effective teamwork
Whenever requested, to provide expert clinical opinion/information to external and internal customers
To cooperate cross functionally with market access, finance, quality affairs, sales and marketing teams
To support Marketing department in the elaboration/review and approval of promotional materials ensuring that all local legal requirements and other applicable (e.g. Ethical codes) as well as those established by the Company Group are met
To ensure sales force medical training on key technical and scientific areas and products
To maintain a “library” of relevant articles, presentations provided by experts to company
To participate at brand teams´ work and campaigns preparation
To prepare Medical Budget and Local Annual Medical plans, to participate on preparation of brand strategic plans with focus on their medical parts
To build and maintain relations with Thought Leaders in main therapeutic areas
To keep high scientific profile and medical knowledge within the relevant therapeutic areas
To ensure medical responsibility for execution of scientific activities related to key products on CE cluster level, to coordinate close collaboration in dystonia/spasticity/aesthetic indication area with respective medical functions in CE cluster, to drive the alignment of implementation of medical plans related to a Product, to manage Product CE cluster advisory boards in respective therapeutic areas and to regularly update cluster medical team about new data in this therapeutic area
Regulatory and Pharmacovigilance
| In area of regulatory affairs to ensure timely and quality submissions to relevant regulatory authorities
To ensure the required medical support to pharmacovigilance responsible person in all matters related to this area, as required by Standard Operational Procedures To act in Superuser role in Medical Information system for Czech Republic |