Medical Excellence Manager, ISS and MAP

Sobi

$120K — $145K *
US-AnywhereRemote in Waltham, MA
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • University degree in Life Sciences or Health Sciences.
  • Minimum of two years' experience in a pharmaceutical company, specifically in Medical Affairs.
  • Knowledgeable in Investigator Sponsored Studies (ISS) and clinical study processes.
  • Experienced in managed access or early access programs.
  • Strong project management, negotiation, and conflict resolution skills.
  • Exceptional analytical and problem-solving abilities with a customer-oriented approach.
  • Highly developed interpersonal skills for diverse stakeholder engagement.

Responsibilities

  • Oversee the ISS review and approval process, ensuring proposal validation and stakeholder communication.
  • Manage the MAP/PTA review and approval processes, coordinating case reviews and documenting decisions.
  • Serve as the global contact for ISS and MAP management for designated products, collaborating with internal and external stakeholders.
  • Maintain databases for ISS and MAP/PTA, tracking proposals and decisions with relevant documentation.
  • Facilitate contract development and negotiation between sponsors/requestors and Sobi.
  • Support supply chain set-up with Affiliate teams for ISS and MAP/PTA programs.
  • Provide regular updates on the status of ISS and MAP/PTA programs to responsible teams and leadership.

Benefits

  • Competitive 401(k) match for financial future.
  • Tuition and wellness reimbursements for personal and professional growth.
  • Comprehensive medical, dental, and vision package for health and well-being.
  • Recognition awards to celebrate employee achievements.
Full Job Description
The Medical Excellence Manager is responsible for managing Investigator Sponsored Studies (ISS), Managed Access Programs (MAP) and Post Trial Access (PTA) Programs. Key responsibilities include: - 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. Qualifications The ideal candidate must possess: - 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. Additional Information Compensation and Total Rewards at Sobi At Sobi, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards. Your total compensation at Sobi goes beyond just your base salary and annual bonus. It also includes a robust suite of benefits, such as: - A competitive 401(k) match to support your financial future. - Tuition and wellness reimbursements to invest in your personal and professional growth. - A comprehensive medical, dental, and vision package to prioritize your health and well-being. - Additional recognition awards to celebrate your achievements. The base salary range for this role is 120,000 - 145,000 USD. Each individual offer will be determined based on several factors, including your experience, qualifications, and location. Additionally, this role is eligible for both short-term and long-term bonuses, as outlined in the plan details.

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