Senior Medical Writer

GE HealthCare

1d•$144,000 - $216,000

About The Position

The Senior Medical Writer role provides medical writing support in the production of clinical research documentation in support of drug development, product registrations and product marketing. 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.

Requirements

Degree: MSc or PhD in a scientific/medical discipline
Minimum of 5 years Medical Writing experience.
Demonstrated ability in the independent production of clinical protocols and reports.
Experience with NDAs, sNDAs, and other regulatory submissions and with electronic regulatory submission requirements (eCTD)

Nice To Haves

Good understanding of the relevant Health Authority Regulations and guidelines and the drug development process
Self-motivated with a proven ability of working to deadlines
Proficiency in MS Office and experience of working with electronic Document Management systems

Responsibilities

Responsible for the writing and editing of medical documents (including, but not limited to, clinical protocols, clinical study reports, clinical sections of regulatory submissions and investigator brochures), ensuring adherence to regulatory guidelines and departmental editorial standards.
Management and prioritization of multiple medical writing projects, acting as senior medical writer
Ensure that documents are reviewed and approved according to the processes described in relevant SOPs and external guidance documents (e.g. ICH-E3 for clinical study reports).
Maintain document standardisation with the use of model documents/templates ensuring the quality of clinical project documentation.
Responsible for the QC of documents written by other authors (including review for scientific content, consistency, and compliance with internal and external guidance documents).
Responsible for importing report appendix documents into the document management system and the creation of published output for clinical study reports in accordance with Regulatory requirements and submission strategies.
Responsible for the review, editing and update of Medical Writer SOPs and Guidelines.
Mentor more junior Medical Writers (Lead MWs and MWs)
Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
Complete all planned Quality & Compliance training within the defined deadlines
Identify and report any quality or compliance concerns and take immediate corrective action as required
Support compliance/closure of Regulatory and Quality requirements before completing Design Outputs/Program Deliverables
Participate in continuous improvement activities by identifying and appropriately escalating process and product quality gaps, providing solutions when possible.