Sobi - Swedish Orphan Biovitrum AB (publ)

Medical Excellence Manager

Sobi - Swedish Orphan Biovitrum AB (publ)

full-time

Posted on:

Location Type: Remote

Location: Sweden

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About the role

  • 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.
Benefits
  • Competitive compensation for your work
  • Emphasis on work/life balance
  • Collaborative and team-oriented environment
  • Opportunities for professional growth
  • Diversity and Inclusion
  • Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
project managementproposal validationcontract developmentnegotiationbudget monitoringdata managementclinical study processesmanaged access programsearly access programsdatabase maintenance
Soft Skills
interpersonal skillscommunicationnegotiationconflict resolutionanalytical skillsproblem-solvingcustomer-oriented mindsetorganizational skillsmultitaskinginitiative
Certifications
university degree in Life Sciencesuniversity degree in Health Sciences