Medical Writer

📋 Description

• Audit, revise, and uphold clinical and regulatory documents, which include Clinical Evaluation Reports (CERs), Clinical Study Protocols and Reports (CSPs/CSRs), Investigator’s Brochures (IBs), Instructions for Use (IFUs), Post-Market Clinical Follow-up (PMCF) plans and reports, as well as risk management documentation. Ensure adherence to relevant regulations and guidelines (ISO13485, ISO14155, ISO14791, MDR, and EU and FDA guidance documents) and applicable Pulse Biosciences Standard Operating Procedures (SOPs).

• Collaborate with teams in Clinical, Regulatory, Quality, Biostatistics, and R&D Engineering to ensure consistent messaging and accurate data interpretation.

• Perform literature reviews and compile clinical data from various sources.

• Review and refine manuscripts for submission and publication in peer-reviewed journals.

• Convert intricate scientific and clinical information into clear, concise narratives that comply with regulatory standards.

• Assist in developing document strategies, timelines, and regulatory submissions (e.g., FDA, PMA, CE marking technical documentation).

• Participate in addressing complex inquiries from notified bodies and stakeholders.

• Ensure document consistency, maintain version control, and uphold audit readiness.

• Contribute to the development of SOPs and the enhancement of processes.

⛳️ Requirements

• A Bachelor’s degree in Life Sciences, Medical Technology, Engineering, a related scientific field, or relevant experience is mandatory.

• Over 5 years of medical writing experience in the medical device or pharmaceutical industry, or 7+ years of general technical writing experience.

• Proficiency in writing, editing, and managing clinical and technical documentation that supports the development of new products and the enhancement of existing ones.

• Experience in supporting FDA submissions.

• Outstanding writing, editing, and communication skills.

• Strong understanding of clinical research methodologies and evidence generation for medical devices.

• In-depth knowledge of ISO 14155 and EU MDR or FDA regulatory requirements.

• Proficient in Microsoft Office Suite applications and document management systems.

• Ability to interpret and create complex clinical data presentations in tabular and graphical formats.

• Proficient in using database tools such as PubMed, EMBASE, or MEDLINE.

• Exceptional scientific writing skills, with the capability to summarize and interpret complex data effectively, concisely, and persuasively.

• Knowledge of additional languages is advantageous.

• Strong attention to detail.

• Ability to work diligently with minimal supervision, exercising good judgment, and taking initiative to complete both short and long-term projects while recommending actions with little direction.

• Capacity to collaborate as a team member, manage multiple projects and deadlines, and adapt flexibly to the evolving priorities and demands of a fast-paced, growing company.

• Ability to lift 10-15 pounds.

🏝️ Benefits

• A range of health insurance plans and supplemental insurance options.

• 401k retirement savings plan.

• Paid time off.

• Paid holidays.

• Flexible work schedule.

• Wellness program, featuring an onsite gym and mindfulness classes.

• Stock options awards.

• Employee Stock Purchase Plan (ESPP) to participate in our success.