Headquartered in Stockholm, Sweden, Swedish Orphan Biovitrum AB is an international biopharmaceutical company dedicated to transforming the lives of individuals
Medical Excellence Manager, ISS, MAP
Location
Massachusetts
Posted
93 days ago
Salary
$120K - $145K / year
Seniority
Mid Level
Job Description
Medical Excellence Manager, ISS, MAP
Sobi - Swedish Orphan Biovitrum AB
• Manage Investigator Sponsored Studies (ISS), Managed Access Programs (MAP), and Post Trial Access (PTA) Programs • Oversee the ISS review and approval process • Manage the MAP/PTA review and approval process • Serve as the global point of contact for ISS and MAP management • Maintain comprehensive databases for ISS and MAP/PTA • Facilitate contract development and negotiation between sponsors/requestors and Sobi • Support supply chain set-up in conjunction with Affiliate teams and Sobi Supply Chain • Provide regular status updates on ISS and MAP/PTA programs • 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
- Highly developed interpersonal skills, coupled with a communicative and adaptable approach.
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
- Medical, dental, and vision package to prioritize your health and well-being
- A competitive 401(k) match to support your financial future
- Tuition and wellness reimbursements to invest in your personal and professional growth.
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