Contract Medical Writer

The Contract Medical Writer assists in managing various aspects of medical writing activities, ensuring efficiency and compliance with regulations. This role encompasses responsibilities such as the research, creation, and editing of protocols, investigator brochures, clinical study reports, pre-IND briefing books, and IND submissions and updates for clinical trials/research (Phase I-IV). The Contract Medical Writer is also responsible for assisting with the development of corporate practices related to document handling, establishing guidance procedures, and ensuring adherence to corporate standards for clinical writing. 

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. 

Other duties may be assigned. Employee performs all, part, and/or any combination of the duties listed below.

QUALIFICATIONS 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. 

EDUCATION and/or EXPERIENCE

SKILLS and/or ABILITIES

Contractor shall be responsible for their own insurance. 

PHYSICAL DEMANDS 

The physical demands described here are representative of those that must be met by a contractor to successfully perform the essential functions of this job. 

While performing the duties of this job, the Contractor regularly reaches with hands and arms. The contractor periodically is required to lift and/or carry up to 10 pounds. Occasionally, contractor stoops, bends, kneels, and crouches; and pushes/pulls filled wheeled carts. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.

WORK ENVIRONMENT 

The work environment characteristics described here are representative of those a contractor encounters while performing the essential functions of this job. 

May work in an office or home office environment where the noise level is largely controlled by the contractor. Contractor may be subject to many interruptions; pressure due to meet deadline requirements; and handling multiple tasks simultaneously while performing assigned duties. 

SAFETY REQUIREMENTS 

In the interest of safety, Lotus Clinical Research contractors should practice safe use of cell phones and other mobile devices while driving on Company business and/or Company time, if applicable.