Senior Staff Medical Writer

This is a fully remote position, open to applicants in Arizona, +4 more states.

📋 Description

• Create and sustain Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF) documents, and other clinical evidence materials that facilitate international product registrations and lifecycle management.

• Gather, assess, and consolidate clinical evidence from clinical trials, published research, post-market data, and additional safety and performance resources into regulatory documents that are ready for submission.

• Address notified body evaluations and regulatory feedback, facilitating the resolution of inquiries related to clinical documentation to ensure continued market access.

• Collaborate with Regulatory Affairs, Clinical Affairs, Quality, Research & Development, and Marketing teams to devise clinical evidence strategies, regulatory documentation plans, and project schedules.

• Draft clinical study protocols, study reports, data summaries, and other supporting scientific documents.

• Perform systematic literature reviews, assess scientific data, and incorporate findings into clinical and regulatory documents.

• Lead document review processes, coordinate feedback from stakeholders, resolve content-related issues, and secure timely approvals.

• Propel continuous improvement efforts, manage medical writing tools and templates, and provide mentorship to junior members of the medical writing team.

⛳️ Requirements

• A Bachelor’s degree in a scientific, technical, healthcare, or related field is required.

• A minimum of 6 years of industry experience in medical technology, medical devices, pharmaceuticals, or healthcare products is necessary.

• At least 4 years of experience in scientific writing, medical writing, clinical research, or related regulatory documentation activities is required.

• Proven experience in authoring Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-Up (PMCF) documentation.

• In-depth knowledge of MEDDEV 2.7/1 Rev. 4, European Union Medical Device Regulation (EU MDR 2017/745), and MDCG guidance for clinical evaluations.

• Experience in conducting systematic literature reviews and utilizing scientific databases, literature search methodologies, and literature management tools.

• Familiarity with FDA regulations, Good Clinical Practice (GCP), ISO 14155, ISO 14971, and relevant international medical device regulations and standards.

• A Master’s degree, PhD, PharmD, MD, MPH, RN, BSN, or other advanced health-related degree is preferred.

• Experience in authoring clinical study protocols, clinical study reports, manuscripts, or scientific publications is advantageous.

• Previous involvement in supporting regulatory submissions and global market access initiatives for medical devices is desirable.

• Understanding of clinical operations, risk management, and international regulatory requirements is essential.

🏝️ Benefits

• Flexible remote work arrangement.

• Commitment to equal opportunity employment.

• 10% travel requirement.