Medical Advisor (Cardiometabolic)

Our client is a leading international biopharmaceutical company focused on developing and delivering innovative therapies for people living with rare and complex diseases. With a strong global presence and a patient-centric approach, the company is committed to advancing scientific innovation and improving outcomes in areas of high unmet medical need.

As member of the Cardiometabolic BU, the Medical Advisor (MA) reports directly to the Therapeutic Area Medical Lead and represents the affiliate’s medical/scientific subject-matter expert for the assigned product(s) and therapeutic area/s, maximizing product value and patient benefit through the development and implementation of the Local Medical Plan (LMP). The Medical Advisor:

• Leads the preparation and execution of strategic pre-launch/launch medical plan(s) and related activities for new products and/or new indications, acting as a valuable partner within cross-functional launch team(s)
• Leads the execution of medical activities for the assigned product(s) and therapeutic area/s, including but not limited to overall medical planning, identification of unmet medical needs, data generation, publications, advisory boards, scientific partnerships with key thought leaders/external experts, and medical education
• Provides medical/scientific input into affiliate medical affairs strategies and, as required, into regional and global medical affairs plans
• Provides medical/scientific subject-matter strategic expertise to cross-functional affiliate teams and ensures that the medical affairs function is fully integrated in co-creating strategy and executing affiliate business objectives, while remaining functionally independent.

Key responsibilities:

• Develop the country medical strategy for the assigned product(s) and therapeutic area(s) in line with the regional/global strategy, country insights and local conditions under the supervision of the Therapeutic Area Medical Lead, and design the Local Medical Plan (LMP) with related projects/activities to be effectively and timely implemented in close collaboration and synergy with the MSL team.
• As budget owner for the assigned therapeutic area/s, secure the medical plan and related activities are accompanied by a concrete budget plan regularly monitored.
• Identify medical education needs, design and implement a high-quality medical communication plan, medical educational meetings (ie: symposia, conferences) and medical/patients materials as appropriate, to advance science and the appropriate use of the assigned product/s.
• Deliver scientific presentations to healthcare professionals individually or in groups (meetings, clinical sessions, etc), where appropriate.
• Gain Thought Leaders / Experts insights by planning, organizing, conducting and timely reporting Medical Advisory Boards to identify, confirm and fulfill the unmet needs around the assigned therapeutic area/s and products.
• Ensure an effective management strategy for external insights from the field in close collaboration with the MSL Manager by defining key insight topics (KITs) and related key insights questions (KIQs), ensuring that the insights are collected and analyzed systematically, reported effectively cross-functionally and translated into actionable initiatives.
• Identify data gap for the assigned therapeutic area/s and product/s between the available data and ideal data set, explore data generation / publication opportunities and, taking into account feasibility, implement a plan to address the unmet needs and maximize patients’ benefit.
• Provide medical/scientific support into the execution of company-sponsored clinical trials and maintain regular contacts with investigators for key studies while securing an appropriate management of Investigator Sponsored Studies within the respective therapeutic area/s.
• Develop strategic scientific partnerships plan(s) with key thought leaders/external experts and other relevant stakeholders (ie: PAGs representatives) who are qualified sources of insight and advice.
• Ensure medical enquiries are timely and appropriately addressed, in accordance with applicable standards response documents.
• Review and approval of non-promotional and promotional materials, securing the integrity and accuracy of scientific/medical data communicated both internally and externally, in compliance with SOPs and local regulations.
• Responsible for the management of Patient Supported Program/s (PSP) and Unsolicited product nominal use requests (ex-CU).
• Responsible for risk identification and assessment, mitigation planning as well as implementation and monitoring of appropriate internal controls within the area of responsibilities.
• Develop and maintain in depth knowledge for assigned product(s) / relevant therapeutic area(s) through attendance / participation at key internal meetings/training sessions, relevant congresses, and seminars and by regular self-study on literature updates.
• Screen relevant literature and other information from relevant scientific societies meetings/conferences and develop summaries of key messages for use within Sobi.
• Monitor the environment for competitive intelligence and communicate, where appropriate, within the Company.
• Deliver training to internal stakeholders and develop/update relevant training materials.
• Act as a trusted partner and a key team player cross-functionally, providing scientific advice and input in the design of local and regional/global strategy and plans. Contribute to the development and scientific accuracy of local core dossiers.
• Ensure all medical activities implemented strictly adhere to the company's SOPs/guidance and local regulations.

Requirements:

• Medical Degree or University degree in other scientific discipline.
• At least 3 years of direct experience in a Medical Affairs role (i.e: MSL, MSL Manager, Medical Manager, etc).
• Preferable experience from medical affairs, medical/clinical science, clinical development, access and health economy.
• Preferable experience in cardiometabolic diseases.
• Preferable experience with new products, pre-launch and launch activities planning and execution.
• Ability to create and foster effective scientific relationship with KOLs.
• Ability to network cross-departmentally with local sales and market access.
• Knowledge of national healthcare system and decision making practices, including regulatory, safety, legal and compliance.
• Proficient user of modern IT and office software.
• Excellent written and spoken communication, as well as presentation skills.
• Keen interest in expanding knowledge for the assigned therapeutic areas/products and business acumen.
• Works independently, individually and broadly across functions, with limited oversight.
• Collaborative, team-oriented approach, able to develop and support synergies across the organization, as well as with key external stakeholders.
• Strategic and Entrepreneurial mindset striving for innovation, with strong customer and patient orientation.
• Proactive, pragmatic and ability to get things done in spite of challenges, with strong planning and organizational skills.
• Able to adapt, prioritize, and work effectively in a fast-paced and changing environment.
• Strong commitment to compliance with rules and procedures, quality and integrity.