Medical Information Scientist, Medical Affairs

Reporting to: Sr. Director, Medical Affairs

Location: United States, Boston, MA

Job Summary

The Medical Information Scientist, Medical Affairs will be accountable for Medical Information systems, processes, operations, and deliverables for Orchard's investigational and approved hematopoietic stem cell - gene therapy (HSC-GT) clinical programs. This individual works in partnership with the broader Medical Affairs organization and with cross-functional partners to ensure effective execution of medical information roles and responsibilities for supported clinical programs. This position requires a professional with established personal and scientific credibility and self-awareness who works well in a collaborative cross-functional environment that includes Patient Advocacy, Diagnostics, Clinical Development, Regulatory, and other functions within the broader organization.

Key Elements and Responsibilities

Responsible and accountable for:

• Oversight of Medical Information systems and processes for

Medical Information database management and quality assurance

Internal sharing of medical information, education, literature alerts, etc.

Medical Affairs content undergoing Medical Review Committee (MRC) review

Other third-party systems / vendors supporting Medical Information activities

• Management of Medical Inquiry systems, content, and responses

Validated system for intake and storage of medical inquiries

Appropriate intake and transfer to database of record (e.g. AEs, PCs, etc.)

Standard response letters (SRLs) and non-standard responses

• Clinical and scientific congress Medical Information activities

Medical Information booth, booth content, and other congress materials

Orchard Medical Affairs staff presence and other congress coverage activities

Post-congress medical information internal and external activities

Alignment with commercial booth, booth content, and other congress materials

• Systems and processes for storing and evaluating managed access requests

Pre-approval access (compassionate use) requests

Other expanded access requests

• Processes for the review of external scientific and medical grant requests

Investigator-initiated study (IIS) / investigator-initiated trial (IIT) grants

Unrestricted medical education grants

Continuing medical education (CME) grants

Other Medical Affairs grant funding requests

• Medical Information / Medical Affairs functional and departmental operations

Development and annual updates to department policies and SOPs

Ensuring access to training on relevant Medical Affairs documents

Establishing and maintaining medical information annual budgets

execution of contracts, purchase orders, and other agreements in collaboration with Finance, Legal, and other colleagues in Medical Affairs

Guidance and oversight of additional operational activities as needed

• Other responsibilities as assigned

Foster and drive Medical Information efforts to:

• Build and maintain infrastructure for accurate, timely and consistent external information

Maintenance and storage of external facing field resources and content

Medical Information representation at key external meetings

Regional scientific and clinical congresses / meetings; including thought leader engagement, session coverage, and booth staffing

• Represent Medical Information and support key internal cross-functional teams

Medical Communications / Publications

Regional and global operations teams

Cross-functional teams (Patient Advocacy, Diagnostics, Clinical Development, Regulatory

Global internal teams (Boston, London, remote)

Other internal forums and teams as requested

• Advance projects and initiatives for Medical Excellence supporting

Medical Affairs capabilities reinforcing value and impact

Medical Information infrastructure, processes, and systems

Evidence dissemination through Medical Publications & Communications

• Other responsibilities as assigned