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
Requirements
Required Knowledge & Skills
•Existing understanding or desire to gain knowledge in:
Biotechnology / pharmaceutical industry
Medical Information and Medical Information systems and operations
Government and industry guidelines, regulations, laws, etc., for appropriate scientific/medical exchange, communication, and compliance with customers
Medical Affairs medical excellence
•Preferred to possess existing understanding or training in one or more areas:
Medical or Molecular Genetics
Clinical Neurology, Neurobiology, or Neurometabolic Diseases
Rare or Ultrarare Diseases
Gene Therapy (GT) and/or Hematopoietic Stem Cell Transplantation (HSCT)
•Skills and ability to:
Understand and interpret clinical data and the scientific literature, interpret new information / complex data sets in order to make recommendations, propose solutions, implement decisions, and inform the business
Develop internal relationships in a matrixed environment, identify departmental needs, and work with cross-functional partners to generate results.
Work independently to execute on operational deliverables; including mapping out key tasks and deliverables for a project, executing the project in line with schedule and budget, working with third party vendors, and managing multiple projects simultaneously
Learn and understand general compliance principles of the pharmaceutical industry, in particular the post-approval environment
Take a proactive, solution-oriented approach to working with teams from different groups, institutions, and functions within the company from different countries across the world
Occasional travel (20%) including overnight to meetings, trainings, conferences, programs, etc. as required
Education
•Advanced Scientific / Healthcare Degree (PhD, PharmD, MD, NP, DVM, or similar)
•Fluency in both spoken and written English