Medical Writer Consultant Jobs

General Scope and Summary

SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for a contract role that is responsible for supporting the Medical Writing team with planning and preparing clinical and regulatory documents (protocol, CSR, IB, clinical sections clinical trial and marketing authorization applications, periodic annual reports, etc.) according to company guidelines and international governmental regulations. This position will function under the guidance and direction of the head of the Medical Writing department. The successful candidate will be an independent, proactive medical writer with experience working in a clinical development environment.

Roles and Responsibilities

• Function as an integral part of the Medical Writing team, which includes external vendors.
• Assist management in projecting resources and perform administrative duties as requested.
• Contribute to the design and maintenance of templates/standards for protocols/reports in accordance with ICH guidelines and medical writing best practices.
• Help ensure a consistent style of presentation of documents to maintain quality and ease of review.
• Perform quality control (QC) review of clinical study reports and other submissions written by other medical writers.
• Interact with colleagues from various functional areas in Clinical Development, Clinical Operations, Medical Science, Medical Affairs, Regulatory, and Program Management as necessary to assist the MW team with planning and preparation of high quality clinical and regulatory documents, including protocols, study reports, investigator brochures, etc., according to company and agency guidelines in order to support drug development under strict timelines.
• Keep management informed on progress documents and other project related information.
• Collaborate with and support the department leadership to ensure continuous improvement and high standards for quality and productiveness.
• Work effectively with company document management system and related tools, templates, and procedures in order to ensure efficient production and publishing of documents and dossiers.

Experience, Education and Specialized Knowledge and Skills