MeiraGTx is a clinical-stage gene therapy company focused on developing potentially curative treatments for patients living with serious diseases. We currently have six programs in clinical development including three ocular indications, a salivary gland condition, and a Parkinson’s disease program. Our initial focus on diseases of the eye, salivary gland and central nervous system is based on the significant unmet medical need coupled with the high potential gene therapy has to provide meaningful clinical benefit in these areas. With headquarters in New York and London, our global footprint provides us the opportunity to partner with leading institutions around the world, allowing us to deepen our understanding of diseases and their progression.
Our team was built with deep expertise in gene therapy development, allowing us to efficiently advance our programs from preclinical to clinical development. Our core capabilities in viral vector design and optimization and gene therapy manufacturing give us a differentiated approach to developing gene therapies. Additionally, we are developing proprietary technology to potentially enable innovative gene therapy treatments whose expression can be turned on and off with an easily administered small molecule. We believe temporal control of gene therapy products has the potential to transform the gene therapy landscape.
Our state-of-the-art manufacturing facility, completed in early 2018, was designed to meet global regulatory requirements, including the current good manufacturing practices (cGMP) required by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the U.S. Food and Drug Administration (FDA). The 29,000-square foot facility has the flexibility and capacity to produce sufficient product for all our clinical trials and will scale to commercial capacity.
Purpose of Job
Manage and execute Medical Writing (MW) activities to ensure the completeness, accuracy and consistency of clinical and regulatory documents in compliance with local and global regulations.
- Work and interact extensively with clinical and regulatory team, biostatistics and data management, pre-clinical, manufacturing, and quality assurance as well as external contacts to ensure high quality of clinical study-related documents, such as but not limited to clinical study protocols, clinical study reports, publications, and Investigator’s Brochures. High quality refers to scientific content, organization, clarity, accuracy, format, and adherence to regulatory and internal guidelines, styles and processes
- Be an active member of the clinical study team
- Support the preparation of Health Authority meeting-related documents
- Support the preparation of the Medical Writing deliverables for the filing of INDs and BLAs/MAAs
- Provide support for activities related to public disclosure of clinical data
- Follow up on timelines and escalate issues, if required
- Lead/participate in process improvement initiatives
- Participate in regulatory agency and internal audits, when appropriate
Key Performance Indicators
- Medical writing deliverables completed on time (and within budget, when outsourced)
- Clinical study and drug license application filings without documentation issues
Key Job Competencies
- Knowledge of ICH-GCP, EU and US regulatory requirements
- Knowledge of common technical document format and e-CTD
- Skills in document management
- Knowledge of the workings of a Clinical Development environment
- Detail oriented, methodical and goal driven
- Strong problem solving and analytical skills
- Strong communication and interpersonal skills
- Able to work independently as well as in a matrixed environment
- MS Office: proficient level (highly proficient in MS Word)
- Fluent in English, written and spoken (highly proficient writing skills)
- Financial authority: none
- Direct reports: none
- Expected educational qualifications: MSc or PhD in relevant field of life sciences or equivalent by experience
- Expected experience: 2-7 years experience in medical writing