Non-clinical Compliance Specialist
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
As the Non-clinical Compliance Specialist, you will be responsible for ensuring the thorough and accurate documentation of studies conducted in the Preclinical Development Department to support progress and submission of novel gene therapies to the authorities.
Review and approve Preclinical Development documentation to support traceability and document integrity.
Support Preclinical Development Lead and other team members to facilitate Preclinical Development studies where requested
- Timely review and approval of non-clinical study documentation
- Management of the Preclinical Department documentation storage and retention in line with site procedures
- Aid internal audit process of non-clinical studies prior to application to the authorities
- Support study protocol and study report writing of non-clinical studies
- Contribute to the accurate and up to date upkeep of SOPs across the team
- Propose and/or support the implementation of continuous improvement programmes
- Assure data integrity and compliance with Preclinical Department policies of all activities with a particular focus on work supporting clinical programmes
- Identify and report potential procedural and documentation problems
- Comply with MeiraGTx procedures including Health and Safety and best industry practice
Key Performance Indicators
- Quality Control KPI’s
- Documentation Integrity
Key Job Competencies
- Experience of working within a quality and data documentation environment, ideally in the pharmaceutical industry.
- A high level of attention to detail and self-motivation to set and achieve challenging goals with thoroughness and accuracy.
- Well-developed organizational and time management skills with a willingness to amend and reprioritise with short notice.
- Problem solving attitude to identify problems in a timely manner and gather information to resolve problems or develop alternative solutions.
- Ability to relate to and communicate with people of different technical skills backgrounds and at different levels within the company.
- Ability to work well independently and willingness to demonstrate persistence to overcome obstacles.
- Professionalism – approaches others in a tactful manner; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments.
- Oral Communication – speaks clearly; listens and gets clarification; responds well to questions; demonstrates good presentation skills; participates effectively in meetings.
- Written Communication – writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.
Non-clinical compliance activities
Review and approval of quality documentation
- Degree in a scientific discipline
- Minimum 1 year experience working in QC or non-clinical study environment
- Experience of quality documentation review and approval e.g. traceability, document IDs, completeness of study documentation
- Proficiency in Microsoft Office software (Word, Excel and PowerPoint)