About the Role

We are looking for a Medical Writer (MW) to join our team in the Office of Medical Affairs. The writer will be primarily responsible for creating and updating regulatory documents for medical devices required by applicable regulations. These MW deliverables include: Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post-Market Clinical Follow-up (PMCF) plans, PMCF Evaluation Reports, Summary of Safety and Clinical Performance (SSCP), Periodic Safety Update Reports (PSUR), Health Canada Summary Reports (HCSR), and other reports as needed. 

This is a remote position, and you can work from home in most locations within the United States.

Responsibilities

• Write, edit, and review MW deliverables which requires gathering appropriate input from stakeholders to inform these deliverables, analyzing relevant data, collaborating with product team for strategy/decisions, facilitating document review processes, and meeting deadlines
• Manage projects identified as team priorities for the current fiscal year 
• Work with product teams across therapeutic application areas to develop and/or update product-specific regulatory documents
• All deliverables are required to be completed in accordance with internal procedures/templates and external guidelines and regulations
• Potential for input into responses to regulatory questions pertaining to the MW deliverables
• Maintain compliance with training expectations and performing additional responsibilities as required within the scope of the position

Required Qualifications

• Bachelor’s Degree and at least three years of experience in medical writing, regulatory writing, and/or advanced degree in a health-related field
• Demonstrated experience in critical and written analysis of medical literature, clinical data, or relevant documents for regulatory submissions
• Excellent computer skills including MS Office (Word, Excel, PowerPoint)
• Highly organized, self-motivated, and extremely detail-oriented
• Excellent written and verbal communication skills
• Proven ability to work independently with minimal supervision, meet deadlines, and manage multiple projects simultaneously
• Ability to collaborate across departments and relate effectively to people at all levels of the company
• Ability to travel up to 5%

Desired Qualifications

• Advanced degree or training in a science/medical-related field OR prior experience in the medical device and/or pharmaceutical industry
• Experience writing EU Medical Device Regulation 2017/745 (MDR) documents or other regulatory writing experience relevant to class III medical devices 

This position offers a remote work arrangement in the country from which the Associate is employed. Eligibility is dependent on the responsibilities of the role and business needs, and the Associate must agree to comply with Gore’s work arrangement policies.

Note: In the United States, restrictions exist for remote work from Alaska, Hawaii and Rhode Island.