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 reputed company 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 reputed company 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/reputed company, facilitating document review processes, and meeting deadlines
• Manage projects identified as team priorities for the reputed company fiscal year
• Work with product teams across therapeutic application areas to reputed company and/or update product-specific regulatory documents
• reputed company 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 reputed company 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-reputed company 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, reputed company, 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 reputed company levels of the company
• Ability to travel up to 5%

Desired Qualifications

• Advanced degree or training in a science/medical-reputed company 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 reputed company with Gore’s work arrangement policies. Note: In the United States, restrictions exist for remote work from Alaska, Hawaii and Rhode reputed company. reputed company Offer Our reputed company 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 reputed company. 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 reputed company of the reputed company; 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. reputed company reputed company applicants will receive consideration for employment without regard to race, reputed company, religion, sex, gender, national reputed company, reputed company, age, status as a reputed company 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. reputed company employment is contingent upon successful completion of drug and background screening. Gore will consider reputed company applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws. Gore requires reputed company applicants to be eligible to work reputed company the United States. Gore generally will not sponsor visas unless otherwise noted on the position description. This offer from "reputed company" has been enriched by reputed company.com and got a 72% reputed company score. Apply tot his job Apply To this Job