Medical Excellence Lead - Waltham, United States - Sobi

Description

Job Description

Role & Function

The Medical Excellence Lead is responsible for the oversight of Investigator Sponsored Studies (ISS); the Managed Access Programs (MAP) and post trial access (PTA).

Key Responsibilities

• Responsible for ISS Process, ISS System and overall oversight of Sobi's ISS portfolio
• Responsible for reporting ISS status to relevant stakeholders and leadership teams, as required
• Responsible for central ISS budget oversight, track milestone payments and to report ISS budget to the responsible budget owners
• Global point of contact for ISS Coordination of certain products, as agreed with the team, towards Study Liaisons, headquarter product/project teams and supporting functions, ISS Evaluation Committee (EC) team members and local affiliate medical personnel
• Responsible for the ISS review & approval process (Validate proposals for completeness, arrange timely product/project specific ISS EC meetings with relevant members, documentation of meeting minutes & decisions, communicate decisions Country teams/external requestors)
• Facilitate development and negotiations of contracts between the Sponsor and Sobi in collaboration with the Study Liaison, product/project team and headquarter supporting functions, as required
• Responsible for coordination of review of ISS proposals by external partners (including participation in joint committees), as required
• Maintain a complete and updated ISS database with full tracking of each ISS proposal/study, including documentation and decisions made (if granted study protocols, agreements, amendments, and other mandatory supporting documentation)
• Support supply chain set-up together with the Country teams and Sobi Supply Chain
• Provide regular status updates of product/project specific ISSs to the responsible Global Medical Director and the ISS EC or RDMA Leadership team
• Coordinate Sobi follow-up of study reporting and arrange for review of study-related publications as appropriate by applicable Sobi functions
• Global point of contact for EGB Coordination towards Study Liaisons, headquarter product/project teams and supporting functions, EGB team members and local affiliate medical personnel
• Responsible for the EGB review & approval process (Validate proposals for completeness, Arrange timely product/project specific EGB meetings with relevant members, documentation of meeting minutes & decisions)
• Maintain a EGB database with full tracking of each proposal/study, including documentation and decisions made
• Responsible for MAP Process, MAP System and overall oversight of all MAPs
• Responsible for central MAP budget oversight
• Global point of contact for MAP Coordination of certain products, as agreed with the team, towards Study Liaisons, headquarter product/project team
• Oversight of the Sobi's MAP based on the feedback received from the direct reports
• Oversight of post trail access activities
• MAP Coordination:
  • Responsible for the review & approval process of MAP requests
  • Arrange timely product specific MAP team meetings with relevant members, documentation of meeting minutes & decisions, communicate decisions Country teams/external requestors or third parties)
  • Facilitate contracts between the requestor and Sobi in collaboration with Legal, and other headquarter supporting functions, as required
  • Maintain a complete and updated MAP database with full tracking of each program / individual request, including documentation and decisions made (if granted study protocols, agreements, amendments, and other mandatory supporting documentation)
  • Support supply chain set-up together with the Country teams and Sobi Supply Chain
  • Provide regular status updates of product specific managed access programs to the responsible Global Medical Director or RDMA Leadership team
  • Follow up Managed access central budget and to report budget to the responsible budget owner

Qualifications

• University degree in Life/Health Sciences
• Knowledge of all aspects of the ISS/ clinical study process
• >12 month of experience in handling of MAP
• Experience in the field of Haemophilia/ Haematology and/or Immunology (desired)
• Experience from a head quarter position (desired)
• Excellent written and oral communication skills in English
• Excellent skills in Microsoft Office platforms
• Excellent project management skills including negotiation and conflict resolution skills

Personal attributes

• Strong interpersonal skills with communicative and flexible attitude
• Ability to work independently with a proactive approach to study coordination
• Excellent problem solving skills
• Strong individual initiative, organization skill and multi-tasking abilities
• Strong customer-oriented mindset In addition, you must demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership.

Location

The position will be based in Flexible.

Reporting to

VP Medical Excellence

Recruitment contact & how to apply

If you are interested in applying for this position, please submit your CV and cover letter through the apply button above.

Sobi is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, or national origin. Sobi is committed to providing access, equal opportunity and reasonable accommodation for individuals with disabilities in employment, its services, programs and activities.

If you are interested in being considered for this role, then please attach an updated copy of your resume (as a MS-Word or PDF file) while submitting your application.

Why Join Us?

We are a global company with around 1,500 employees in more than 30 countries, and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we're ready to take on the world's diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others' lives because that's exactly what we do here. If you're seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.

We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.

Sobi Culture

At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them.

As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them.

This has been our approach since day one, but we know we can't change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain.

Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.

An Equal Opportunity Employer

Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate.

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