GE Healthcare
Published
October 12, 2021
Category
Other  
Job Type
Work Setting
Remote / Home-based

Description

The Medical Writer partners with Subject Matter Experts, Medical Directors, and the research team to create clinical study-related documents in accordance with ICH, regulatory authority, and/or GEHC guidelines. Creates a variety of clinical documents necessary for all phases of clinical research by organizing, analyzing, and interpreting scientific and statistical data. May also assist with regulatory submissions and will conduct medical literature searches as required.

GE Healthcare is a leading global medical technology and digital solutions, innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Job Description

Roles and Responsibilities

  • Create clinical study-related documents in accordance with ICH, regulatory authority, and/or GEHC guidelines including clinical study reports, study protocols, informed consent forms, and other clinical documents as applicable.
  • Works with manager and Research Program Integrator to ensure research activities are run compliantly and according to project timelines.
  • Attend internal and external meetings as necessary for each project (e.g., Project Kick-off meeting, Sponsor team meetings, Project team meetings).
  • Reviews statistical analysis plans and case report forms, as required.
  • Performs quality control (QC) review of clinical study protocols and other submissions written by other medical writers.
  • Keeps management informed on progress on documents and other project-related information, assists management in projecting resources, and performs administrative duties as requested.
  • Conduct medical literature searches as required.
  • Ensure Research is executed in compliance with Good Clinical Practices and other applicable regulations and company procedures.

Required Qualifications

  • Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 6 years of experience in the healthcare industry.
  • Clinical Research experience including a minimum of 3 years of clinical writing experience within the bio-pharmaceutical or medical device industry. (Medical Device research preferred.)
  • Working knowledge of ICH and other regulatory guidelines.

Desired Characteristics

  • Experience conducting medical literature searches, analyzing and writing reports on the results of such searches.
  • Experience interfacing with Regulatory Agencies such as the FDA; experience with BIMO inspections
  • Knowledge of Quality Management Systems (QMS.)
  • Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.

Additional Information

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.

GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).

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