Senior Medical Writer

Achieve Your Ambition

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.

Areas of Responsibility & Tasks

• Writing and editing of medical documents (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
• Reviewing and approving documents according to relevant SOPs and external guidance documents
• Maintaining document standardization using model documents/templates
• QC of documents written by other authors
• Importing report appendix documents into the document management system and creating published output for clinical study reports
• Updating Medical Writer SOPs and Guidelines
• Mentoring more junior Medical Writers (Lead MWs and MWs)
• Complying with GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations
• Identifying and reporting quality or compliance concerns and taking immediate corrective action
• Supporting compliance/closure of Regulatory and Quality requirements before completing Design Outputs/Program Deliverables
• Participating in continuous improvement activities by identifying and escalating process and product quality gaps, providing solutions when possible

Required Qualifications

• 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)

Preferred Qualifications

• 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

Benefits

• Medical, dental, vision, paid time off
• 401(k) plan with employee and company contribution opportunities
• Life, disability, and accident insurance
• Tuition reimbursement

Equal Opportunity Employer

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.

Compensation

The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI).

GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.

Additional Information

• GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation.
• GE HealthCare 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 HealthCare will only employ those who are legally authorized to work in the United States for this opening.
• While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.