Leading Pharmaceutical Company is looking for Medical Director Russia & CIS
Medical Affairs
MD shall assume responsibility for the following Medical Affairs activities:
KOL development and networking
Advisory Board and Expert meeting planning and management
Internal product training, therapy area training and compliance training
Approval of promotional and medical communication material
Provide scientific support as needed
Internal and external scientific medical information and Q/A
Support Commercial and Market Access as needed
Phase 4 study activities:
Responsible for Idea generation/planning/ and participate in execution -
of IITs, Observational studies and phase IV trials.
All above activities must be done in collaboration with local, regional and headquarters stakeholders.
Regulatory Affairs and SPV
Regulatory activities related to New products in Russia & CIS
Regulatory activities related to existing products in Russia & CIS
Active external and internal pharmacovigilance activities to insure high level of risk management related to product & trials circulated in Russia & CIS
All above must be coordinated on domestic and international levels (HQ) to insure compliance with regulatory and SPV for both local and HQ requirements and relevant GLs & SOPs
Clinical Development
MD must ensure following:
Support of all clinical trial activities in Russia and Ukraine and ensure a high level of quality in these activities
Local expertice in therapy area, relevant products, and in medical monitoring expertice
Give input to local/regional/global development plan as needed
Ensure strong network with current and future investigators
Optimise collaboration with CROs
Provide input to corporate and local on local CROs and investigators
Ensure optimal use of Russia’s potential for regional and global trials
Support functions to regional clinical trials by housing and supporting relevant specialist functions such as Clinical Research Management.
People Management
Ensure the necessary organisation, people and competencies
Manage, develop and retain talented employees.
Ensure that people can work in a true matrix organization, by allowing relevant functions to partly report elsewhere in the organization.
Prepare and follow-up on budget and estimates for the area of responsibility according to given time frames
Reporting lines
MD reports to the regional Medical Director for all clinical development matters, and all functional aspects of medical/clinical/scientific activities.
MD reports to the local GM, with regards to aligning medical/regulatory activities with goals in the local commercial organization, and with regards to admin aspects
Profile
Medical background
International Pharma Company experience is a must
Experience for similar position with similar duties and responsibilities from 2 years
Strong professional and managerial skills in Clinical trials and Medical Affairs
Wide network of contacts in relevant fields
English fluent