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Medical Excellence Manager, ISS and MAP

External
Sobi logoSobi · Waltham, MA
Full-timeRemote3mo ago
DocumentationLeadershipNegotiation
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Benefits

Health insuranceDental insuranceVision insurance401(k)Performance bonus

Additional Information

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. 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. Compensation and Total Rewards at Sobi At Sobi, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards. Your total compensation at Sobi goes beyond just your base salary and annual bonus. It also includes a robust suite of benefits, such as: 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. The base salary range for this role is 120,000 - 145,000 USD. Each individual offer will be determined based on several factors, including your experience, qualifications, and location. Additionally, this role is eligible for both short-term and long-term bonuses, as outlined in the plan details. 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 1,900 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 that's exactly what we do here. If you're 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 can't change the world of rare diseases on our own. Accomplishing this requires


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