Просмотр вакансии

• Budget: Accountable for the local budget of Medical Function. Manages the budget planning for medical activities and function. Monitors spend against budget and ensures accurate reporting.
• Medical Governance: Accountable for Medical Governance within the Country Organization in front of the Medical Affairs management.
• Supervision and due diligence for all activities promoted or induced by the company that directly or indirectly involve exposure of a human being to any pharmaceutical product of the Bayer Group. Such supervision and due diligence must be such as to enhance the benefit-risk ratio for user, product and company.
• Responsible for setting and maintaining a culture of the highest ethical standards for any medical activity, which the Country Subsidiary is involved. Responsible together with the Country Divisional Head to ensure that the personnel of the local organization are adequately trained on the processes related to Drug Safety and Product Quality (handling of adverse effect reports and / or product quality complaints).
• Must ensure that all medical personnel are familiar with and adequately trained in the basic ethical, scientific, legal, and related principles governing medical and related activities within the Pharmaceutical Industry and their implications concerning following key processes:
  1. Product information
  2. Labeling
  3. Medical information (information on medical questions and information about products)
  4. Pharmacovigilance and Drug Safety
  5. Clinical Activities: studies / trials; registries, Patient Support Programs etc.
  6. Management of crisis related to products or to medical activities
• Supervision and due diligence for studies conducted in Belarus Regarding Investigator Sponsored Trials and Collaborative Group Sponsored Trials the Medical Director is responsible to ensure that the conduct of the study is in accordance to the applicable regulations and terms of contract in such a way that the participating subjects / patients are not exposed to unnecessary risks.
• Responsible to ensure that the local labeling is compliant with the labeling references laid down by the Global Labeling Committee and Global Safety Committee.
• Management: Manages and implements all medical activities in Belarus by leading the appropriate functional groups to cover the following:
  1. Pharmacovigilance and Drug Safety
  2. Clinical Development
  3. Clinical Activities: studies / trials; registries, etc.
  4. Medical information
  5. Medical training
• Responsible for the interface with the respective global functions e.g. GRA, GCD, GCO related to the respective matrix organization between country and global functions.
• As a supervisor, responsible to lead and develop direct reports, as well as personnel who report in to these direct reports.
• Strategy and implementation: Contributes to the establishment of the Regional strategy providing the adequate local input. Represents Belarus in all aspects related to medical activities in which Belarus participates, is involved or its participation or involvement is considered. Ensures the implementation of the agreed strategy by executing the agreed plans.
• Develops and guides local Thought Leader (TL) management strategy, together with marketing and country organization.
• Promotes the participation of the Country Medical Function on Regional Strategic teams looking either at new drug development products or at further development of existing product ranges.
• Cross-functional support:
  • Responsible for promoting cross-functional support between the Medical Department and the local
  • Marketing and Sales Departments. Every avenue must be explored to ensure that cross-functional working of this nature produces the optimal conditions in terms of business efficiency, staff morale and high quality output
  • Ensures optimal cross-functional support at a local level. Ensures that this cross-functional support is maintained and enhanced at every opportunity
  • Provide product safety, medical information and other medical related services to the company and external customers, in order to accomplish a high level of commercial success
  • Responsible for ensuring that there is adequate support from within the Medical Department for activities such as TL support and promotional material approval
  • Ensure provision of medical expertise and training to internal and external customers, medical staff, Marketing and other commercial functions as required
• Clinical activities:
  • Enables the local organization to participate in Clinical Development Programs by developing the local infrastructure and defining strategic study concepts in co-operation with Medical, Marketing and Clinical Development functions
  • Manages, designs and develops the conduct of local and regional study activities (post-registration and investigator-led) in agreement with the defined strategy
  • Ensures that any post-registration or investigator-led study activity is evaluated and approved according to the Combined Assessment Procedure described in the SOP
  • Is responsible for signing off protocols and final study reports for “domestic” studies
  • Is responsible for establishing processes and communication lines and is involved in any decisions making that occur when fraud is suspected in a study
  • Is responsible for the supervision and due diligence for all clinical studies and activities including Patient Support Programs according to the SOP conducted in Belarus sponsored or supported by any Company or Affiliate of Bayer HealthCare
• Drug safety and quality:
  • Accountable for the outstanding operation of the Pharmacovigilance Systems in the Country Subsidiary.
  • This entails a close cooperation with the local Drug-Quality function.
  • Provides a Local Pharmacovigilance Country Head (PVCH), ensures the nomination of the PVCH by the Regional Medical Director, enables the appointee to perform the related duties and ensures a state of the art relationship with the Product Quality function, as foreseen in the relevant procedures.
• Medical information:
  • Accountable for the medical accuracy and correctness and for the ethical tenability of any information provided by the local subsidiary of Bayer on medical topics, be it related to Bayer products or not.
  • Ensures that any promotional and educational materials distributed by or on behalf of Bayer in the respective country has been approved according to SOPs.
  • Ensures that all information requests coming from customers, users or patients are managed according to the relevant SOPs and that the information provided is accurate and balanced
  • Ensures that any press release or publication of any nature issued by or on behalf of Bayer in the respective country is accurate, compliant to internal SOPs and in line with applicable local and international laws and regulations
  • Follows global/ regional guidance in the use of standard responses, Question and Answer standards, compliance requirements.

• Education:
  • Degree on Human Medicine.
  • Fluent in English and in the main official language of the Country.
• Experience:
  • At least 4 years work experience in the pharmaceutical sector in Medical Affairs, Clinical Development or related positions. Experience in the therapeutic areas covered by BAYER.
  • Successful record of at least one year in project management.
  • Experience (at least 1 year) in the field of medical support of a product portfolio of at least 20 different products.
  • Familiar with at least one therapeutic area indication including epidemiology, disease patterns and therapeutic options.
  • Advanced knowledge of international pharmaceutical laws, standards and codices.

Официальное трудоустройство в РБ