S
WalthamFull TimeHealthcare
Remotely
Listed on 2 job boards, which is a stronger signal than one board alone.
medical affairsproject managementlife sciencesnegotiationinvestigator sponsored studieshealth sciencesclinical study processesmanaged access programs
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Job Description
📋 Description
- Oversee the ISS review and approval process, including proposal validation, coordination of
- Manage the MAP/PTA review and approval process, including coordination of case reviews, decision
- Serve as the global point of contact for ISS and MAP management for designated products, working
- Maintain comprehensive databases for ISS and MAP/PTA, tracking proposals, studies, and decisions
- Facilitate contract development and negotiation between sponsors/requestors and Sobi, collaborating
- Support supply chain set-up in conjunction with Affiliate teams and Sobi Supply Chain for both ISS
🎯 Requirements
- A university degree in Life Sciences or Health Sciences, demonstrating a strong academic foundation
- A minimum of two years' experience within a pharmaceutical company with experience in Medical
- 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
- Exceptional analytical and problem-solving abilities, coupled with a robust customer-oriented
🎁 Benefits
- Competitive 401(k) match
- Tuition and wellness reimbursements
- Comprehensive medical, dental, and vision package
- Additional recognition awards
- Short-term and long-term bonuses
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