Швейцарська фармацевтична компанія, одна з провідних компаній світу у галузі фармацевтики та діагностики відкриває вакансію Медичного директора.
The Country Medical Director provides strategic direction and leadership to the local Medical centre. Contributes to the leadership and management of the Affiliate by providing strong functional expertise and ensuring it adheres to the highest scientific and ethical standards and fulfils all regulatory and compliance requirements. Contributes to the collective Medical leadership of the Company and to the appropriate use of Roche products. Represents medical authority with key external stakeholders.
Your Key Responsibilities:
Leadership and Management
- Develop and lead a highly motivated and well-trained team with an objective- and performance-led culture and ensure skilled staff and services in place to support execution of operational plans.
- Manage the budget/resources allocated to projects in order to meet objectives and targets.
- Built excellent relationships and interactions between Medical and other Affiliate and Global functions.
Medical strategies and tactics
- Leadership of medical strategy development through his / her own medical expertise and that of the Medical Manager team.
- Ensure Affiliate Medical Plans optimally integrate Life Cycle Team and Affiliate objectives through an appropriate mix of pRED, gRED, PD, PBS and Affiliate clinical trials and investigator selection.
- Ensure strategic partnerships with KOLs, patient groups and scientific institutions and societies to enable optimal support for products throughout their lifecycles.
- Ensure medical and product information is provided in compliance with Global SOPs and local regulatory requirements and that all data used in the provision of Medical information are accurate and meet the needs of internal and external customers.
Clinical trial activities
- If appropriate, develop medically sound, feasible, affiliate studies that enhance product knowledge.
- Ensure optimal investigators selection by a constructive dialogue between medical and clinical operations.
- Ensure all local clinical trials and contracts are appropriately approved; executed within agreed timelines and budget; in accordance to ICH/GCP, SOPs, quality standards, and regulatory requirements.
Compliance and training
- All medical activities must comply with Company policies, guidelines, SOPs, GCP and ethical standards and local legislation.
- Ensure medical review and approval of all promotional materials in compliance with Codes of Practice, Company SOPs, and local regulations.
- Verify the accuracy of training material for scientific and product information and drug safety reporting requirements to the local organization (including the sales force).
- Medical Affairs staff are fully trained and compliant to Company SOPs and that any issues identified during audits are resolved.
- Oversight of the safety of local clinical activities.
- Processing and reporting of relevant safety information in compliance with local regulatory requirements and Roche SOPs.
- Establish effective relationships with Regulator and other national authorities to achieve registration of and access to products and approval of clinical trial applications.
Education: Medical Degree. Strongly desired: Pharmaceutical medicine training; Higher degree and/or specialist accreditation; Business qualification e.g. MBA
Experience and Capabilities:
- 5+ years relevant professional experience within the pharmaceutical industry and/or CRO, preferably in development and/or medical affairs function at a local or regional level
- Has developed and implemented local Phase III & IV trials
- Has leading and mentoring experience with proven results in team management
- Has good judgment and is a strong decision-maker
- Has experience with Key Opinion Leader relationship management
- Proven ability to identify and resolve complex clinical trials methodology problems
- Strong and influential presenter and communicator, with the ability to establish external partnerships with relevant partner organizations and stakeholders in the wider arena, and/or to act as an ambassador for Roche and for MA activities
- Broad Medical Expertise and understanding of HC system, policy trends and future pipeline, such that they can work on future-based solutions
- Proven ability to take insights from the medical community and translate them into company strategy
- Proficient in English to collaborate internally
- In-depth understanding of medical and strategic aspects of all drug development stages, including supported and non-interventional studies; comprehensive knowledge of ICH GCP and the local legislation on clinical trials;
- the national product licensing process, including appeals, amendments and renewals; safety reporting legislation and process;
- comprehensive awareness of international and national codes of practice, including laws and guidelines on promotional activity;
- familiarity with the local medical environment and healthcare system; familiarity with the disease areas set as a priority for the Company;
- sound knowledge of project management tools and processes
We are waiting for your resume
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