Medical Writing

This a Full Remote job, the offer is available from: United States 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.

What We Offer

Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow. We provide benefits that offer choice and flexibility and promote overall well-being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for “profit-sharing”. Learn more at gore.com/careers/benefits Gore is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a protected veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations. Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening. Gore will consider qualified applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws. Gore requires all applicants to be eligible to work within the United States. Gore generally will not sponsor visas unless otherwise noted on the position description. This offer from "W. L. Gore & Associates" has been enriched by Jobgether.com and got a 72% flex score. Apply tot his job Apply To this Job