GE HealthCare Medical Writer 

United Kingdom, England 

188779148

To provide medical writing support and expertise in the production of clinical research documentation for drug development and product registrations.Responsibilities:

• Preparation of Clinical Documents: Write and edit high quality clinical documents, including clinical protocols, study reports, regulatory submission sections, and investigator brochures. Co-ordinate review and approval of documents following SOPs and external guidelines (e.g. ICH-E3 for clinical study reports). Provide support to other departments (e.g., nonclinical).

• Maintain Document Standardization: Use templates to ensure quality and consistency. Perform scientific review and quality checks of others’ documents to ensure compliance with document standards and guidelines.

• Use of Document Management Systems: Import documents into the document management system and co-ordinate creation of published outputs.

• Update SOPs and Model Documents: Review and update Medical Writing SOPs and model documents in line with latest guidelines.

• Ensure Quality Compliance: Follow quality manuals and policies, complete compliance training, and report any quality issues.

Requirements:

• Educational Background: Degree, MSc, or PhD in a scientific or medical field.

• Experience: Demonstrated experiencein medical writing in industry, with proven ability to produce clinical protocols and reports independently and a knowledge of ICH and health authority guidelines.

• Skills: Excellent communication and time management, proficiency in MS Office, and experience with electronic document management systems.

Desired Characteristics:

• Self-Motivated: Able to work independently and co-ordinate workload across a number of projects to meet deadlines.

• Detail-Oriented: Maintain high standards of quality and consistency. Excellent proof reading skills.

• Problem-Solver: Identify and address process and product quality gaps.

• Team Player: Provide support to other medical writers and other functions and participate in continuous improvement.

• Technical Knowledge: Proficiency in MS Office and familiarity with Document Management Systems

Total Rewards

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.