Medical Excellence Manager, ISS, MAP

ManagerManagerFull TimeRemoteMid LevelTeam 1,001-5,000Since 1991H1B No SponsorCompany SiteLinkedIn

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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