Medical Excellence Manager, Iss and Map

**Company Description** **_ At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients. Here at Sobi, our mission and culture get us excited to come to work every day, but here are a few more reasons to join our team: - Competitive compensation for your work - Emphasis on work/life balance - Collaborative and team-oriented environment - Opportunities for professional growth - Diversity and Inclusion - Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments The Medical Excellence Manager is responsible for the management of Investigator Sponsored Studies (ISS), Managed Access Programs (MAP) and Post Trial Access (PTA). **ISS process** - Responsible for managing the ISS review and approval process, to include: - Validation of proposals for completeness, coordination of review of proposals, timely arrangement of ISS Evaluation Committee (EC) meetings, documentation of EC meeting decisions, communication of decisions to Affiliate teams/external requestors. - Is the Global point of contact for ISS management for certain products, as agreed with the team, working with a variety of cross-functional internal and external stakeholders. - Maintains a complete and updated ISS database with full tracking of each ISS proposal/study, including relevant documentation and record of decisions made. - Facilitates the development and negotiation of contracts between the Sponsor and Sobi in collaboration with the legal function, MPL, the Affiliate teams and other functions, as required. - Supports supply chain set-up together with the Affiliate teams and Sobi Supply Chain. - Coordinates Sobi follow-up of study reporting and arranges review of study-related publications, as appropriate, by applicable Sobi functions. - Responsible for milestone payment tracking and reporting ISS budget to the budget owners. - Provides regular status updates of product/project specific ISSs to the responsible teams and leadership, as needed. **MAP/PTA process** - Responsible for managing the MAP/PTA review and approval process, to include: - Coordination of review and approval of requests, arrangement of timely product specific MAP team meetings with relevant members, documentation of meeting decisions, communication of decisions to Affiliate teams, external requestors and third parties. - Is the Global point of contact for MAP management for certain products, as agreed with the team, working with a variety of cross-functional internal and external stakeholders. - Maintains a complete and updated MAP database with full tracking of each program / individual request, including relevant documentation and record of decisions made. - Facilitates contract development between the requestor and Sobi in collaboration with Legal, and other functions, as required. - Supports supply chain set-up together with the Affiliate teams and Sobi Supply Chain. - Provides regular status updates of product MAPs to relevant stakeholders, the responsible teams and leadership, as needed. **Qualifications** Education/Learning Experience/Work Experience** - Required:_ - University degree in Life/Health Sciences - Knowledge of the ISS/clinical study process - >12 months of experience in handling of MAP **_ Desired:_** - Experience in the field of Haemophilia/ Haematology and/or Immunology - Experience from a head quarter position **Skills/Knowledge/Languages** **_ Required:_** - Excellent written and oral communication skills in English - Excellent skills in Microsoft Office platforms - Excellent project management skills including negotiation and conflict resolution skills **Personal Attributes** - Required:_ - Collaborative, Accountable, Respectful and Engaged (Sobi CARE values) - Strong interpersonal skills with communicative and flexible attitude - Ability to work independently with a proactive approach to study coordination - Excellent problem solving skills - Strong individual initiative, organization skill and multi-tasking abilities Strong customer-oriented mindset_**Additional Information** All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease. **Why Join Us?** We are a global company with over 1,700 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because tha