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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.
Collaborate closely with internal and external teams, including Programming, Biostatistics, Regulatory Operations, Quality Operations and Project Management.
Develop and maintain document templates tailored for clinical trials.
Create and maintain writing guides specific to clinical trials.
Lead the development and implementation of study protocols and any protocol amendments.
Provide comprehensive medical writing support throughout the lifecycle of clinical trial studies, including regulatory submissions and various required documents.
Initial Investigational New Drug (IND) applications and amendments Protocols and protocol amendments Investigator brochures and updates Interim and final clinical study reports IND annual reports Ensure all clinical study documentation complies with regulatory requirements.
Proactively coordinate and execute activities in accordance with Standard Operating Procedures (SOPs).
Manage project timelines and projections proactively.
Ensure project quality through Quality Control of work.
Actively engage in sponsor/project team meetings.
Contribute to departmental and organizational meetings and initiatives.
Maintain open communication with cross-functional groups throughout the project lifecycle and monitor project scope.
Cultivate and maintain key vendor relationships when applicable.
Perform other miscellaneous duties as required.
Participate in corporate initiatives related to SOPs, standardization efforts, methods, techniques, and evaluation criteria for projects, programs, and personnel.
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
EDUCATION and/or EXPERIENCE BS/BA in a health-related or life science-related field. Master’s degree preferred.
A minimum of 5 years of relevant experience in medical writing is required.
Demonstrates extensive experience in the design, execution, and analysis of clinical studies.
Experience in the Contract Research Organization (CRO) industry is preferred.
Familiarity with industry principles of drug safety, US and international regulatory guidelines, drug development, biostatistics, pharmacology, and clinical trial methodology.
Knowledge of clinical research including regulatory requirement GCP/ICH.
Strong interpersonal skills.
Proficiency in Microsoft Office and computer skills.
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.
