Senior Medical Writer

Job Description Summary

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.

Job Description

Areas of responsibility & tasks

• 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.

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

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.

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We will not sponsor individuals for employment visas, now or in the future, for this job opening.

For U.S. based positions only, the pay range for this position is $144,000.00-$216,000.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. 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. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).

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.

Relocation Assistance Provided: No