Medical Program & Engagement Manager CEE+

Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.

• International and country level medical engagement projects management (internal and external scientific events, HCPs logistics management, scientific communication projects).
• Support and lead defined stages in the defined geographies Medical Programs management: Managed Access (compassionate Use), Evidence Generation, Scientific Communication and Medical Training / Education Programmes
• Tracking timelines, budgets and project KPIs and reporting as appropriate

Major Key Responsibilities:

• • Execute and manage medical projects, events and activities
  • Medical Programs management incl MAP program support scientific communication and trainings
  • Optimizing medical processes and communication channels
  • Tracking and reporting KPIs and project/program milestones

Key responsibilities:

1. Country level and international project management:
   • Leading medical projects for maximal scientific impact from planning to execution incl budget and time management, aligning to local medical Implementation plans and reporting relevant KPIs:
     1. In scope: internal and external medical events for clusters/countries (logistics, customer contracts, liaison with HCPS and vendors), other scientific projects, HCPs logistics management, scientific communication projects.
   • Supporting globally or regionally leading HCP customers in scope of premier medical projects for Sobi and creating spotless experience for the customers within supervised projects from initiation, through any virtual or face to face interaction to close-out, providing strong Scientific knowledge with sense of value creation 
   • Managing approval of items in Electronics Approval System (Veeva Vaults)
   • Provide hands on financial management (raising purchase orders, managing contracts, supporting invoice management, financial reconciliation, budget tracking), communicating with 3rd party vendors
   • Identifying opportunities to enhance current ways of working, leveraging internal and external best practices
   • Ensures internal training, planning and execution in the organization in support of launch readiness and cross-functional collaborations.
   • Contributes to functioning quality management system for the medical team in compliance with Global and regional SOPs and their ongoing updates
2. Medical Programs management:
   • Scientific Communication, Evidence Generations and Training programs as defined
   • Managed Access / Compassionate Use
     1. Facilitate effective communication and collaboration with the global MAP team to ensure alignment and consistency in processes
     2. Ensure the preparation and execution of MAP documentation in compliance with Sobi and Romanian legislation for all types of requests (initial supply, re-supply)
     3. Ensure, in collaboration with affiliate regulatory and medical department that all local conditions for product use for the registered indication are met (eg. aRMM received by treating physician, CDRN, as applicable), including for submission to Health Authority
     4. Conduct meetings with clinic management and healthcare professionals (HCPs) as part of the MAP process
     5. Facilitate development and negotiation of the donation contract / MAP letter agreement between the requestor and Sobi, supported by the Legal Counsel, as required
     6. Provide support for other specific MAP requests as per business needs, ensuring timely and efficient responses to emerging requirements
     7. Liaise with Local Supply, MAP Coordinator and other functions, as needed, to ensure smooth product supply
     8. Sends notifications to the requestor to ensure that HCP and pharmacy are properly informed about local NDA approval and expected supply date

Education/Learning Experience

• pharmacist, biological science or business university degree
• 3 years’ experience in pharmaceuticals or complex FMCG environment managing complex end-to-end activities and interfacing VIP/KOL customers on regular basis
• Experience of working with different stakeholders and teams
• Fluency in written and spoken English
• Strong computer literacy
• Knowledge of health system and healthcare decision making, including regulatory, safety, legal and compliance environment
• Experience in managing execution of medical activities and programs within the context of pharmaceuticals industry

Skills/Knowledge

• Able to establish credible and long-lasting professional relationships and has personal impact through engaging respectfully and professionally
• Focus on personal accountability and ownership – constantly challenging oneself to take responsibility for continuous performance improvement and operational excellence Ability to execute independently upon clear guidance and instruction, with good judgement on when to escalate or when to involve a broader team
• Experience or ability in managing complex end-to-end activities and events which may occur anywhere globally
• Ability to handle expectations from VIP/KOL customers

Personal Attributes

• Behaves with high level of autonomy – identifies challenges and needs, acts accordingly initiating projects with impact on business outcomes
• Excellent interpersonal skills with ability to lead, facilitate, interact with, focus, negotiate, resolve conflict and drive consensus among individuals from a variety of cultures and disciplines
• Ability to operate in a highly complex and dynamic environment engaging cross-functional and x-country teams without co-location or authority
• Ability to make effective prioritization to deliver business-critical items on time in a complex and fast-paced environment
• Structured and organized approach, in a flexible and adaptable spirit
• Highest levels of personal integrity, with a strong personal commitment to adhere to all rules, regulations, Standard Operating Procedures and the Sobi values and ethics, compliance to rules and regulations
• Willingness to adapt and adjust areas of responsibility and focus according to the demands of the business
• Willingness and flexibility to travel within the country and abroad
• Availability to attend meetings on holidays and weekends

This role will be office based with the possibility to work from home in agreement with the line manager. Candidates need to be flexible to travel to business meetings and support Sobi activities at international and regional meetings.