## Medical Manager CNSApply: Dubai, United Arab Emirates: Full time: Posted Today: JR **Company:**0724 A. Menarini Middle East & Africa FZ-LLC**Contract Type:**Permanent **Join us in shaping the future of Menarini - with passion, integrity, and a deep commitment to people.**About Menarini Group - Menarini is a leading international biopharmaceutical company committed to advancing health through innovation, research, and quality. For more than 135 years, we have worked to improve patients’ lives across a broad range of therapeutic areas through our dedication to science, integrity, and care for people. With a strong foundation in scientific excellence and a purpose-driven culture, Menarini offers diverse career opportunities for professionals eager to make a meaningful impact on global health.We are hiring a "Medical Manager CNS", for our growing team in Dubai - UAE. **DESCRIPTION AND AIM**As a Medical Manager you are accountable for developing a Medical and Scientific Affairs team in the business area of responsibility. This Role contributes to the collective Medical leadership of the assigned therapeutic area by ensuring it adheres to the highest scientific, regulatory and ethical standards. The role provides strategic medical direction for the portfolio and leads the regional M&SA activities for these therapeutic areas. It develops and leads the implementation of the strategies and tactics defined by Regional Medical & Scientific Affairs Function, to increase medical awareness and demonstrate our products' clinical value through educational activities and partnerships with healthcare professionals and their associations in the respective markets and disease segments. **MAIN RESPONSIBILITIES AND SCOPE****Medical Strategy & Planning*** Identify unmet medical needs in the assigned therapeutic areas and markets, and address questions and concerns raised by the scientific community.* Identify key knowledge gaps in the medical and scientific field, and propose appropriate action plans.* Lead the implementation of relevant Scientific Affairs projects in the assigned region.* Develop the annual Medical Plan, strategy and tactics for the assigned products and countries, and develop clinical messages for the product line to support the countries.* Implement tools and KPIs to monitor the medical activities for the assigned portfolio.* Identify and build relationships with national, regional and international KOLs and thought leaders.* Contribute to and support the clear articulation of a compelling, scientifically sound brand strategy for the assigned portfolio across Marketing and Sales. **Medical Information & Scientific Education:*** Ensure that all 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, balanced and meet the needs of internal and external customers.* Provide the medical content for, and support the organisation of, key national and regional scientific events (e.g., satellite symposia).* Deliver presentations on scientific, clinical and technical topics in response to unsolicited requests, ensuring appropriate approval in the relevant systems.* Attend relevant scientific congresses to interact with HCPs, develop knowledge in the relevant therapy areas and produce congress summaries for dissemination to internal and external stakeholders.* Support the dissemination of product and disease area knowledge across A. Menarini in line with business priorities.* Regularly communicate best practice and facilitate knowledge sharing across functions and geographies.* Develop scientific slide decks and deliver internal training (including product and disease training for Marketing and Sales), in coordination with the medical information team.* Gather and report competitive intelligence from the assigned region, in line with company policy. **Compliance & Training**:* Ensure that all medical activities comply with company policies, guidelines and SOPs, ICH-GCP, ethical standards and local legislation.* Perform the medical review and approval of all promotional and non-promotional materials and activities for the assigned products, in compliance with the IFPMA and EFPIA Codes of Practice, company SOPs and local regulations, with a duty of care to the reputation of the company.* Identify and contribute to areas of best practice and process improvement.* Adhere to all applicable laws and regulations and to the high integrity standards set by Menarini. **Advisory Boards**:* Set up and organise Scientific Advisory Boards to gather input on disease areas, treatment algorithms, clinical data, protocol design and educational needs, in line with company contracting and fair-market-value procedures. **Health Economics / Market Access**:* Support the market access strategy by providing medical and scientific input, including clinical and real-world evidence, to health economic dossiers and formulary and tender submissions. **Clinical Research Activities:*** Provide field-based medical support to the Company's clinical research programmes as required.* Contribute to the effective and efficient delivery of IIR and non-interventional studies through all phases (start-up, conduct and close-out), in accordance with appropriate quality standards, including ICH-GCP and applicable regulations.* Develop medically sound and feasible study protocols, CRFs, budgets and site training materials.* Assess IIR proposals and manage the related grants, prioritising research that enhances product knowledge.* Ensure optimal investigator selection through constructive dialogue between Medical and Clinical Operations.* Ensure all local studies and contracts are appropriately developed and executed within agreed timelines and budget, in accordance with applicable directives, SOPs, quality standards and regulatory requirements.* Provide direction and oversight of outsourced activities to ensure CRO and vendor delivery against the contracted scope of work.**Drug Safety / Pharmacovigilance**:* Maintain thorough knowledge of applicable local and international pharmacovigilance regulations, including EU GVP and GCC GVP guidelines.* Carry out duties according to relevant SOPs, working instructions and policies, as well as applicable regulations and guidelines, with due care to the quality of the work.* Contribute medical input to signal evaluation, risk management plans and additional risk minimisation measures (aRMMs) for the assigned products.* Perform other duties as necessary at the appropriate scientific and technical level.* undefined **Company Procedure & Follow-Up Process*** Comply with the data integrity policy and commitment.* Monitor and analyze processes, and ensure that the necessary improvement actions are taken.* Maintain, back up and archive (or ensure that this is done for) all records under their responsibility, and destroy those records when the defined retention period expires.* Fulfil the responsibilities defined in all company procedures.* Manage processes in accordance with company procedures, ensuring that inputs and outputs are correct, resources are sufficient, processes are monitored, records are kept and performance is measured, and reporting on these when necessary. **Required Qualificatin**:**Education Level:** Degree in Medicine (MD/MBBS) or Pharmacy; a Master's or PhD degree from a globally recognized institution is plus.**Education Faculty / Department:** Medicine or Pharmacy**Work Experience:** Minimum 10 years of experience in the pharmaceutical industry in Medical Affairs, including at least 5 years as Medical Manager (or equivalent) in specialty care (preferably CNS) or a relevant therapeutic area, and experience working with senior business leaders, clinicians and regulatory authorities.**Technical Knowledge:*** Scientific expertise in Medical Affairs activities in GCC markets.* Experienced in developing and coaching colleagues.* Sound knowledge of GCC health authority, pharmacovigilance and promotional code requirements.**Foreign Language:** Fluent in Arabic & English **Competencies & Skills:*** Strong skills in researching scientific and medical information, with excellent communication and presentation skills.* Strong ability to assess and summarise scientific and technical information clearly and concisely for a specific audience.* Highly organized, with the ability to prioritize own tasks and those of others, good planning skills and strong negotiating and influencing skills.* Able to drive multiple projects with competing priorities, and to think strategically through complex opportunities.* Able to make decisions and recommendations that are aligned with the overall business and product portfolio strategy.* Ability to build productive working relationships both internally and externally.* Ability to work effectively with cross-functional teams and influence appropriate plans and actions.* Networking skills and the confidence to interact with senior experts on a peer-to-peer level.* Ability to examine data, formulate reasonable hypotheses, and design and execute analyses to test them.* Strong analytical reasoning and sound medical judgement and decision-making skills.* Commitment to keeping up to date with the scientific literature.* Ability to work independently; a demonstrated self-starter.* A high level of emotional intelligence to work effectively with stakeholders.
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