Medical Writer

🕒 May 12

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Pulse Biosciences, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2016

🧬 Biotechnology

Healthcare • Biotechnology • Medical Device

Pulse Biosciences, Inc. is a pioneering company in bioelectric medicine, specializing in the development of its proprietary Nanosecond Pulsed Field Ablation (nsPFA) technology for healthcare applications. The company focuses primarily on innovative treatments in cardiology, particularly for conditions such as atrial fibrillation, utilizing their CellFX platform to improve patient outcomes. Through rigorous research and development, Pulse Biosciences aims to enhance cardiac care, offering groundbreaking solutions that promise safer and more effective treatment options across various therapeutic areas.

📋 Description

• Audit, edit, and maintain clinical and regulatory documents, including Clinical Evaluation Reports (CERs), Clinical Study Protocols and Reports (CSPs/CSRs), Investigator’s Brochures (IBs), IFUs, Post-Market Clinical Follow-up (PMCF) plans and reports, and risk management documentation. Ensures compliance to applicable regulations and guidance’s (ISO13485, ISO14155, ISO14791, MDR, and EU and FDA guidance documents) and applicable Pulse Biosciences SOPs • Collaborate with Clinical, Regulatory, Quality, Biostatistics and R&D Engineering to ensure aligned messaging and data interpretation • Conduct literature reviews and synthesize clinical data from multiple sources • Review and edit manuscripts for submission and publication in peer-reviewed journals • Translate complex scientific and clinical information into clear, concise and regulatory-compliance narratives • Support document strategy, timelines and regulatory submissions (e.g. FDA, PMA, CE marking technical documentation) • Involved in responses to complex queries such as those issued by notified bodies and stakeholder • Maintain document consistency, version control, and audit readiness • Contribute to SOP development and process improvements

🎯 Requirements

• BS in Life Sciences, Medical Technology, Engineering, related scientific field or relevant experience required • 5+ years of medical writing experience in the medical device or pharmaceutical industry or 7+ years general technical writing • Writing, editing and managing clinical and technical documentation utilized in the development of new products and improvement of existing products • Experience supporting FDA submissions • Excellent writing, editing and communication skills • Strong knowledge of clinical research methodologies and evidence generation for medical device • Strong knowledge of ISO 14155 and EU MDR or FDA regulatory requirements • Proficient knowledge and skill in Microsoft Office Suite applications and document management systems • Ability to interpret and create complex tabular and graphical clinical data presentations • Proficiency in using database tools, such as PubMed, EMBASE, or MEDLINE • Excellent scientific writing skills, including an ability to summarize and interpret complicated data effectively, concisely and persuasively • Knowledge of additional languages is an asset • Strong attention to detail • Ability to work conscientiously and with minimal direction, using good judgment, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction • Ability to work as a team member, manage multiple projects and deadlines and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic, fast-growing company • Ability to lift 10-15 pounds

🏖️ Benefits

• A variety of health insurance plans and supplemental insurance options • 401k retirement savings plan • Paid time off • Paid holidays • Flexible work schedule • Wellness program, including onsite gym and mindfulness classes • Stock options awards • Employee Stock Purchase Plan (ESPP) to share in our success