• Write, edit and review reports
• Manage projects
• Gather appropriate input from stakeholders and analyze relevant data
• Collaborate on decisions
• Facilitate document review processes, and meet deadlines
• Work with product teams across therapeutic application areas to develop and/or update product-specific regulatory documents which are required to be completed in accordance with internal procedures/templates and external guidelines and regulations
• Maintain compliance with training expectations and perform additional responsibilities as required within the scope of the position

Required Qualifications:

• Bachelor’s Degree and a minimum 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

Desired Qualifications:

• Advanced degree or training in a science, engineering, or medical field
• Prior experience in the medical device and/or pharmaceutical industry and / or experience with writing document types specific to the role or experience with regulatory writing relevant to the role
• Familiarity with EU Medical Device Regulation 2017/745 (MDR)

Hybrid Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore’s hybrid working policies, from the country in which they are employed.

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

We believe in the strength of a diverse and inclusive workplace. With diverse perspectives, ideas and experiences, we uncover new possibilities and make a greater impact in the world. We are proud of Associates for building on our rich history of innovation, upholding our values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.

Gore is an equal opportunity employer. We welcome all applications irrespective of 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 covered 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 U.S. Gore generally will not sponsor visas unless otherwise noted on the position description.

Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact

• Travel%: 5
• Shift: Day Job
• Schedule: Full-time