Medical Excellence Manager

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.

Qualifications :

The ideal candidate must possess:

• 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.

Additional Information :

All Sobi employees need to demonstrate behaviors in line with Sobis 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 1900 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 were ready to take on the worlds diseases ailments and adversity. Our people believe they have the power to make a positive impact in others lives because thats exactly what we do here. If youre seeking a career that taps into your talents in a way that makes the world a better healthier place we just may have a job for you.

We know our employees are our most valuable asset and our culture conveys that. We offer a competitive benefits package to support the health and happiness of our staff.

Sobi Culture

At Sobi we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases and have used this knowledge to shape our business to find new ways of helping them.

As a specialized biopharmaceutical company we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one but we know we cant change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients partners and stakeholders across the entire value chain. Together we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.

An Equal Opportunity Employer

Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs job requirements and individual qualifications without regard to race color religion or belief national social or ethnic origin sex (including pregnancy) age physical mental or sensory disability HIV Status sexual orientation gender identity protected veterans and/or expression marital civil union or domestic partnership status past or present military service family medical history or genetic information family or parental status or any other status or protected groups by the laws or regulations in the locations where we operate.

Sobi is an affirmative action and equal opportunity employer. Disabled/Veterans. If you are a qualified individual with a disability or a disabled veteran you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to

Remote Work :

Yes

Employment Type :

Full-time