Medical Excellence Manager

Sobi•Waltham, MA

About The Position

The Medical Excellence Manager is responsible for managing Investigator Sponsored Studies (ISS), Managed Access Programs (MAP) and Post Trial Access (PTA) Programs. Key responsibilities include: Oversee the ISS review and approval process, including proposal validation, coordination of reviews, and communication of decisions to stakeholders. Manage the MAP/PTA review and approval process, including coordination of case reviews, decision documentation, and communication with relevant parties. Serve as the global point of contact for ISS and MAP management for designated products, working with cross-functional internal and external stakeholders. Maintain comprehensive databases for ISS and MAP/PTA, tracking proposals, studies, and decisions with relevant documentation. Facilitate contract development and negotiation between sponsors/requestors and Sobi, collaborating with legal, MPL, and other functions as required. Support supply chain set-up in conjunction with Affiliate teams and Sobi Supply Chain for both ISS and MAP/PTA programs. Provide regular status updates on ISS and MAP/PTA programs to responsible teams and leadership. Monitor milestone payments and report ISS budget to budget owners. Coordinate with vendors on the set-up and management of MAP and PTA programs as needed.

Requirements

A university degree in Life Sciences or Health Sciences, demonstrating a strong academic foundation in the field.
A minimum of two years' experience within a pharmaceutical company with experience in Medical Affairs
Comprehensive knowledge of the Investigator Sponsored Studies (ISS) and clinical study processes
Proven experience in handling managed access or early access programs
Superior project management skills, including excellent ability to negotiate effectively and resolve conflicts
Exceptional analytical and problem-solving abilities, coupled with a robust customer-oriented mindset, strong individual initiative, superior organizational skills, and the ability to effectively multitask in a demanding environment.
Highly developed interpersonal skills, coupled with a communicative and adaptable approach, essential for working with diverse stakeholders.

Responsibilities

Oversee the ISS review and approval process, including proposal validation, coordination of reviews, and communication of decisions to stakeholders.
Manage the MAP/PTA review and approval process, including coordination of case reviews, decision documentation, and communication with relevant parties.
Serve as the global point of contact for ISS and MAP management for designated products, working with cross-functional internal and external stakeholders.
Maintain comprehensive databases for ISS and MAP/PTA, tracking proposals, studies, and decisions with relevant documentation.
Facilitate contract development and negotiation between sponsors/requestors and Sobi, collaborating with legal, MPL, and other functions as required.
Support supply chain set-up in conjunction with Affiliate teams and Sobi Supply Chain for both ISS and MAP/PTA programs.
Provide regular status updates on ISS and MAP/PTA programs to responsible teams and leadership.
Monitor milestone payments and report ISS budget to budget owners.
Coordinate with vendors on the set-up and management of MAP and PTA programs as needed.

Benefits

Competitive compensation for your work
Generous time off policy
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
A competitive 401(k) match to support your financial future.
Tuition and wellness reimbursements to invest in your personal and professional growth.
A comprehensive medical, dental, and vision package to prioritize your health and well-being.
Additional recognition awards to celebrate your achievements.