Medical Excellence Manager, ISS and MAP at Sobi

Waltham, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

11 Jun, 26

Salary

145000.0

Posted On

13 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Investigator Sponsored Studies (ISS) Management, Managed Access Programs (MAP) Management, Post Trial Access (PTA) Programs, Proposal Validation, Stakeholder Communication, Cross-functional Collaboration, Database Maintenance, Contract Development, Negotiation, Supply Chain Support, Budget Monitoring, Vendor Coordination, Project Management, Conflict Resolution, Analytical Skills, Problem-Solving

Industry

Pharmaceutical Manufacturing

Description

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 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 Job Description 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 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 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. 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 [email protected] Know Your Rights Sobi Location: United States

Responsibilities

The Medical Excellence Manager will oversee the review and approval processes for Investigator Sponsored Studies (ISS), Managed Access Programs (MAP), and Post Trial Access (PTA) programs, serving as the global point of contact for these management activities for designated products. Key duties include maintaining comprehensive databases, facilitating contract negotiation, supporting supply chain setup, and providing regular status updates to leadership.