[Hiring] Contract Medical Writer @Evolution Research Group

Role Description

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:

• 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).
• 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:

• Collaborating closely with internal and external teams, including Programming, Biostatistics, Regulatory Operations, Quality Operations, and Project Management.
• Developing and maintaining document templates tailored for clinical trials.
• Creating and maintaining writing guides specific to clinical trials.
• Leading the development and implementation of study protocols and any protocol amendments.
• Providing comprehensive medical writing support throughout the lifecycle of clinical trial studies, including regulatory submissions and various required documents such as:
• 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
• Ensuring all clinical study documentation complies with regulatory requirements.
• Proactively coordinating and executing activities in accordance with Standard Operating Procedures (SOPs).
• Managing project timelines and projections proactively.
• Ensuring project quality through Quality Control of work.
• Actively engaging in sponsor/project team meetings.
• Contributing to departmental and organizational meetings and initiatives.
• Maintaining open communication with cross-functional groups throughout the project lifecycle and monitoring project scope.
• Cultivating and maintaining key vendor relationships when applicable.
• Performing other miscellaneous duties as required.
• Participating in corporate initiatives related to SOPs, standardization efforts, methods, techniques, and evaluation criteria for projects, programs, and personnel.

Qualifications

• 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.

Requirements

• Excellent organizational skills.
• Strong written and verbal communication skills.
• Exceptional attention to detail.
• 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:

• Regularly reaches with hands and arms.
• Periodically required to lift and/or carry up to 10 pounds.
• Occasionally stoops, bends, kneels, and crouches; and pushes/pulls filled wheeled carts.
• Specific vision abilities required 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.
• May be subject to many interruptions; pressure due to meeting 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.