Medical Affairs Operations and Medical Information Scientist

3 weeks ago

Boston, United States Orchard Therapeutics Full time
Job DescriptionJob Description

Reporting to: Sr. Director, Medical Affairs

Location: United States, Boston, MA

Job Summary

The Medical Affairs Operations and Medical Information Scientist 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

· Supporting the 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

· Supporting the 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

­ Establishing and maintaining medical information annual budgets

­ Supporting the 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 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

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