What can we offer you?

Apart from job satisfaction, we can offer you:

HEALTH

• Medical, Dental and Vision benefits for you and your family, including Flexible Spending Accounts (FSA)

YOURSELF

• Paid time off policy including holidays and sick time
• Internal growth and development programs & trainings

WEALTH

• 401(k) program, life & accident insurance and disability insurance

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 these documents 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 not only provide standardization and consistency across projects but is a game changer due to the subsequent increases in efficiencies with document development.

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

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 and in collaboration with sponsor teams based on regulatory guidelines.

• Authors Independent Reviewer Training Manuals to support the reader training process based on the Charter and/or Methodology, eCRF, and visualization software.

• Authors MINT configurations to support visual assessments.

• Authors final Study Reports as applicable.

• Develops document templates, as required by operational leadership, to create efficiencies and develop standard look and feel across documents.

• Supports content development of a standard library of reusable text to create efficiencies in document authoring.

• Oversees and coordinates document development for assigned projects.

Education:

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

Experience:

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

Qualifications:

• Strong communication skills
• Excellent grasp of SOPs
• Excellent written and verbal communication skills
• Solid organizational skills, including attention to detail and ability to multi-task