General Electric Lead Medical Writer in Lynn, Massachusetts
Job Description Summary
The Medical Writer partners with Subject Matter Experts, Medical Directors and 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.
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, assist management in projecting resources, and perform 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.
Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 6 years of experience in healthcare industry.
Clinical Research experience including 3+ years clinical writing experience within the bio- pharmaceutical or medical device industry. (Medical Device research preferred.)
Working knowledge of ICH and other regulatory guidelines.
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.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
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.
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer (https://assets.phenompeople.com/CareerConnectResources/GE11GLOBAL/en_global/desktop/assets/images/poster_screen_reader_optimized_w_supplement.pdf) . 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).
As a federal government contractor, GE may in the future be required to have U.S. employees fully vaccinated against COVID-19. Some GE customers currently have vaccination mandates that may apply to GE employees.
Relocation Assistance Provided: No