Medical Writer (Remote, US) (Boston, MA, US)

About This Opportunity

Our talent team at Get A Job.ai is representing a confidential medical device organization seeking a Medical Writer to join their clinical affairs function. This is a remote position available to candidates across the United States, with preference for those in the Eastern time zone. This role offers the opportunity to contribute to life-saving medical technology through comprehensive clinical documentation and regulatory compliance work.

This is initially a fixed-term position with strong potential to convert to a permanent role based on performance and business needs.

Responsibilities

• Lead and participate in clinical evaluation teams to develop Clinical Evaluation Reports (CER) and associated documentation in accordance with MEDDEV 2.7/1 Revision 4 and EU MDR requirements
• Contribute to planning, literature review, and the identification, appraisal, and analysis of clinical data for regulatory submissions
• Support development of Summary of Safety and Clinical Performance documentation aligned with EU MDR
• Participate in Post-Market Clinical Follow-up (PMCF) activities, including literature reviews and clinical data analysis
• Perform comprehensive, systematic literature reviews using PubMed, Embase, and other medical databases to support clinical evaluations and protocol development
• Analyze available clinical evidence to inform clinical development strategy
• Write and edit clinical study documentation including protocols, Investigator's Brochures, periodic reports, and Clinical Study Reports
• Ensure all study documentation meets quality standards and is submission-ready for regulatory agencies
• Serve as subject matter expert on clinical aspects of technical documentation
• Develop manuscripts for peer-reviewed medical journals based on clinical study data
• Prepare abstracts and submissions for medical congresses and symposia
• Contribute to development and optimization of Clinical Affairs standard operating procedures

What We're Looking For

• Bachelor's degree in a relevant scientific discipline, or equivalent combination of education and experience
• Minimum 3 years of medical writing experience; direct experience with clinical evaluations in the medical device industry is a strong plus
• Medical writing certification preferred
• Exceptional attention to detail with demonstrated ability to ensure accuracy
• Strong working knowledge of EU MDR (2017/745), EU MDD (93/42/EEC), MEDDEV guidance (including 2.7/1 Rev 4 and 2.12/2 Rev 2), relevant MDCG guidance, ISO 14155, and ICH guidance (E3, E6 R3 GCP)
• Familiarity with risk management regulations including ISO 13485 and ISO 14971
• Proficiency in navigating PubMed, Embase, and other literature search engines; experience with DistillerSR, EndNote, and similar tools a plus
• Excellent project management skills with ability to meet corporate timelines and objectives
• Strong analytical, organizational, and problem-solving abilities
• Outstanding written and oral communication skills
• Ability to work independently and collaboratively within cross-functional teams
• Professional demeanor when interacting with physicians and medical professionals
• Ability to prioritize effectively in a fast-paced environment and work under urgent deadlines
• Advanced proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint)
• Willingness to travel as projects require

How We Work With You

When you apply through Get A Job.ai, our experienced recruiting team will review your qualifications and conduct an initial screening. We'll discuss your background, career goals, and how this opportunity aligns with your expertise. Once we've confirmed you're a strong match, we'll submit your profile to our client for consideration. Please do not contact the hiring organization directly—all communication and coordination will flow through our team to ensure the best possible experience and outcome.

Pay

Pay via Get A Job.ai will be discussed during the screening process and is competitive with market rates for medical writing professionals with this level of experience.

Equal Employment Opportunity: Get A Job.ai is committed to inclusive hiring practices and equal opportunity employment. We welcome all qualified applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.