Sobi - Swedish Orphan Biovitrum AB (publ)
rare strength
Medical Excellence Manager, ISS, MAP
Location
Massachusetts
Posted
33 days ago
Salary
$100K - $140K / year
Seniority
Mid Level
Bachelor Degree2 yrs expEnglish
Job Description
• 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.
Job Requirements
- A university degree in Life Sciences or Health Sciences
- 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
- Generous time off policy
- Opportunity to broaden your horizons by attending popular conferences
- Emphasis on work/life balance
- Collaborative and team-oriented environment
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