Medical Affairs Operations Manager

Company Description

Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!

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.

Our mission and culture at Sobi North America 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
• Generous time off policy
• Summer Fridays
• Opportunity to broaden your horizons by attending popular conferences
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

Please note: Candidates need to be based on the US East coast - candidates located near Waltham, MA preferred. 

Job Description

The Medical Affairs Operations Manager will be responsible for direct operational and logistics support of Sobi Inc.’s key brands from a Medical Affairs perspective and will be embedded within the Brand-Medical-Team (BMT) operating model. Additionally, the successful candidate will lead both short and longer-term departmental projects in alignment with key business and team initiatives. This role will help drive execution of key tactics and deliverables while providing project management and logistics support (budgeting, analytics/metric reporting, medical materials creation/submission, etc.) for cross-functional activities and programs as well, which require a high-level of collaboration within the Sobi organization, in the Waltham office and globally, as well as with external vendors.

Key Responsibilities:

• Lead, contribute to, and track process on brand and above-brand programs to ensure strategic focus and timely execution of deliverables. This includes coordination of interna and external timelines and deliverables, leadership of team efforts and progress monitoring, and collaborating cross-functionally within the Sobi organization to ensure seamless execution of various Medical Brand Plans.
• Provide operational efficiencies by implementing process improvements, providing guidance and support to team members, quickly identifying resolutions to issues, and developing communication plans to engage key stakeholders and increase program-related communication across the organization. This role also will act as a resource for strategy/plan related inquiries and will provide insights that will aid decision-making.
• Optimize achievement of overarching program strategy, including identifying process improvements, instituting best practices, supporting development of tools, templates and reports, and implementing feedback from team members.
• Management of team sites and project tracking tools to maximize communication updates and ensure content maintenance in-line with industry best practices; assess user feedback on an ongoing basis to prioritize future enhancements and improvement areas.
• Provide medical conference logistics including compliance submissions, booth registrations/logistics, medical materials delivery, and
• Handle assigned medical education grant proposals from intake through compliance submission and contracting.
• Deliver advisory board support from venue logistics through compliance documentation and HCP contracting/payment.
• Contribute to RWE programs including, but not limited to, planning, contracting, technical execution, and study reports (abstracts, posters, manuscripts).
• Project management of specific medical plan deliverables, including coordinating strategy/scope development, logistics and vendor management, and coordinating logistics and content development for events and trainings, as applicable.
• Provide contract support with external vendors which may include defining project scope, negotiation, and execution.
• Lead the planning and execution of ad hoc projects by ensuring that projects are aligned with U.S. objectives, supported by executive leadership, and have timely completion.
• Contribute to the development of processes and tools that continuously improve resource utilization and quality of clinical study activities and deliverables.
• Contribute to general operational MA activities including but not limited to budget management, vendor oversight, external meeting coordination, Medical Information and Pharmacovigilance operational activities, Metrics tracking and re