Medical Writer I

1. 25 days' holiday (with the option to buy more)

1. Private Healthcare
2. Optional dental insurance, health assessments and health cash plans
3. Cycle to Work scheme

1. Company Pension Scheme, matching contributions up to 5% of salary
2. Life assurance
3. Annual staff bonus scheme
4. Season ticket loans

The Medical Writer I plays a critical role in the development, editing, and finalization of study-specific documents, a number of which may be used for a client's or Invicro's regulatory submissions. The Medical Writer I not only develops these documents but manages them through to finalization in support of successfully meeting client's timelines. The Medical Writer I actively contributes to a library of imaging document templates that provide standardization and consistency across projects, increasing efficiencies with document development.

The Medical Writer I supports multiple Invicro teams with document development, including Project Management, Reader Management, Imaging Services, and the New Haven and London clinics.

Responsibilities include:

1. Authors study-specific documents for multiple therapeutic areas, such as Technical Operations Manuals, Independent Review Charters, and Methodologies, based on details pulled from the study protocol in collaboration with sponsor teams based on regulatory guidelines.
2. Authors Independent Reviewer Training Manuals to support the reader training process based on the Charter and/or Methodology, eCRF, and visualization software.
3. Authors MINT configurations to support visual assessments.
4. Authors final Study Reports as applicable.
5. Develops document templates, as required by operational leadership, to create efficiencies and develop a standard look and feel across documents.
6. Supports content development of a standard library of reusable text to create efficiencies in document authoring.
7. Oversees and coordinates document development for assigned projects.

Master's degree in Life Sciences/Health Related Sciences or equivalent experience.

1. 3 years of experience writing scientific, medical, or technical content, preferably in a clinical research setting.
2. Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines.

1. Strong communication skills.
2. Excellent grasp of SOPs.
3. Excellent written and verbal communication skills.
4. Solid organizational skills, including attention to detail and ability to multi-task.