Remote Duke Rn Jobs in Anaheim, CA (NOW HIRING)

As the Senior Staff Medical Writer, you will develop scientific and clinical documentation that supports global regulatory compliance and market access for medical devices. This position partners closely with Regulatory Affairs, Clinical Affairs, Quality, Research & Development, and Marketing teams to translate complex clinical evidence into high-quality regulatory and scientific documents throughout the product lifecycle.

What You Will Do

• Author and maintain Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF) documents, and other clinical evidence documentation supporting international product registrations and lifecycle management.

• Compile, analyze, and synthesize clinical evidence from clinical studies, published literature, post-market data, and other safety and performance sources into submission-ready regulatory documents.

• Respond to notified body reviews and regulatory feedback, driving resolution of clinical documentation questions to support ongoing market access.

• Collaborate with cross-functional teams to develop clinical evidence strategies, regulatory documentation plans, and project timelines.

• Author clinical study protocols, study reports, data summaries, and supporting scientific documents for regulatory and clinical initiatives.

• Conduct systematic literature reviews, evaluate scientific data, and integrate findings into clinical and regulatory documentation.

• Lead document review cycles, coordinate stakeholder feedback, resolve content issues, and obtain timely approvals.

• Drive continuous improvement initiatives, maintain medical writing tools and templates, and mentor junior medical writing team members.

What You Need

Required

• Bachelor's degree in a scientific, technical, healthcare, or related discipline.

• Minimum 6 years of industry experience within medical technology, medical devices, pharmaceuticals, or healthcare products.

• Minimum 4 years of experience in scientific writing, medical writing, clinical research, or related regulatory documentation activities.

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

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

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

• Knowledge of FDA, Good Clinical Practice (GCP), ISO 14155, ISO 14971, and applicable international medical device regulations and standards.

Preferred

• Master's degree, PhD, PharmD, MD, MPH, RN, BSN, or other advanced health-related degree.

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

• Experience supporting regulatory submissions and global market access initiatives for medical devices.

• Knowledge of clinical operations, risk management, and international regulatory requirements.