Medical Excellence Manager, ISS and MAP

Sobi
Waltham, MA

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 100,000 – 140,000 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

Posted 2026-02-15

Recommended Jobs

Adult Direct Care Worker up to $27/hr

ProPivotal Staffing
Amherst, MA

Adult Direct Care Worker up to $27/hr Are you driven to make a meaningful difference in the lives of individuals with intellectual and developmental disabilities? Step into the role of an Adult Di…

View Details
Posted 2026-01-26

Senior Quality Management Systems Specialist / Engineer

Biomedical Resource Consultants, Inc.
Fitchburg, MA

About the Position: Title: Sr. Quality Management Systems Engineer Growth potential: Manager of Quality Location: Central MA Compensation: TBD based in experience and fit Reports to: D…

View Details
Posted 2026-01-16

Kids' Corner Program Staff Member

West Suburban YMCA | Newton, MA
Newton, MA

The WSYMCA is seeking Kids' Corner Program Staff Members to join our Childcare team at our Church St location! Are you passionate about working with young children? Want to work for a well-known commu…

View Details
Posted 2026-01-17

Transporter

Cambridge Health Alliance
Cambridge, MA

Requisition Number: 10076 Pay Range: $16.98 - $28.28 per hour Location: CHA Cambridge Hospital  Work Days: 8:00am - 4:30pm weekend shift   Category: Service and Trade   Department: Transporte…

View Details
Posted 2026-01-28

Assistant Professor - Mathematics

University of Massachusetts Boston
Boston, MA

Job Description   The Department of Mathematics at the University of Massachusetts Boston invites applications for a tenure-track Assistant Professorship in Mathematics starting September 1, 2026. T…

View Details
Posted 2025-10-01

Pharmaceutical Kit Packaging Tech - 1st Shift

North Billerica, MA

Now Hiring: Kit Packaging Technician I – Be Part of Something Bigger! Location: North Billerica, MA Industry: Pharmaceuticals | Shift: 1st shift (6AM-4:30PM) M-Th w/overtime on Friday.      Type: Full…

View Details
Posted 2026-02-06

Executive Assistant to Dean of University ($40/hr)

ProPivotal Staffing
Cambridge, MA

Executive Assistant to Dean of University ($40/hr) This is a fantastic opportunity for a seasoned Executive Assistant who thrives in fast-paced, high-stakes environments and is eager to make a sign…

View Details
Posted 2026-01-20

Mental Health Therapist

SonderMind Careers
Shrewsbury, MA

Mental Health Therapist at SonderMind Careers summary: A Mental Health Therapist at SonderMind delivers compassionate, licensed therapy services using AI-powered tools that reduce administrative t…

View Details
Posted 2026-02-06

Senior Cost Estimator - Heavy Civil Construction

OnlyHire.Me
Wellesley Hills, MA

Senior Cost Estimator – Heavy Civil Construction Location: Wellesley Hills, MA Country: United States Salary: $100K-$130K Start Date: Description: Our client is a leading provider…

View Details
Posted 2025-09-10

Financial Controller - Precision Machining Solutions - Base Salary to 150k/year - Boston, MA

AllSearch Professional Staffing
Boston, MA

Financial Controller - Precision Machining Solutions - Base Salary to 150k/year - Boston, MA ~ Our client offers Global Manufacturing Solutions: Precision Machining, Sheet Metal Fabrication, Painti…

View Details
Posted 2026-01-14