کارشناس امور پزشکی و LTO

Job Description

Accountable for: ● Medical and LTO strategy for the affiliate. ● All non-promotional activities (including budget accountability). ● Data-generating activities. ● Knowledge-sharing including medical information, medical education, congress activities, and publications. ● Research and educational grants. ● Strategic partnerships, including TAE interactions. ● Pharmacovigilance. ● Compliance with company and regulatory guidelines. Media communication on medical issues and when applicable: ● Clinical operations. ● Regulatory affairs. ● Health economics/market access. Leadership/Management: ● Develop and lead a highly motivated and well-trained team with an objective- and performance-led culture and ensure skilled staff and services are in place to support the execution of operational plans. ● Manage the budget/resources allocated to projects in order to meet objectives and targets. ● Build excellent relationships and interactions between Medical and other affiliate and global functions. Medical and LTO strategies and tactics: ● Leadership of medical strategy development through his/her own medical expertise and that of the medical manager teams. ● 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 TAEs, patient groups, and scientific institutions and societies to enable optimal support for products throughout their lifecycles. Medical and LTO Information: ● Ensure medical, LTO, 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 investigator 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 with 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 with company SOPs and any issues identified during audits are resolved. Drug safety/pharmacovigilance: ● Oversight of the safety of local clinical activities. ● Processing and reporting of relevant safety information in compliance with local regulatory requirements and Roche SOPs. Regulatory affairs: ● Establish effective relationships with regulatory, reimbursement, and other national authorities to achieve registration of and access to products and approval of clinical trial applications. Health economics/market access: ● Provide data and advice to support the creation of a dossier of health economic data information for market access applications. General (mandatory): ● Attend/complete all requisite on-line and F2F training (role-specific, safety responsibility, and compliance) within the specified time limit ● Identify, collect, and immediately report all safety-related information on Roche products to local safety responsible as per Roche requirements and local regulations ● Adhere to company (both local and global) policies and procedures at all times, including health and safety requirements.