Cer Specialist / Medical Writer (Contract)

Give hope. Give health. Make your mark in the fight against cancer.

At Accuray, we make a direct and powerful impact on the lives of cancer patients every day — helping them live longer, better lives. But our commitment to innovation offers a truly unique opportunity: the chance to change the fight against cancer — helping to develop, introduce and support new treatment delivery systems and software that will give new hope and new health to cancer patients and cancer survivors around the world.

Accuray develops, manufactures and sells radiotherapy systems for alternative cancer treatments. Our radiation therapy for cancer makes treatment shorter, safer, personalized and more effective, ultimately enabling patients to live longer, better lives.

Summary

The Global Quality Assurance department seeks a Clinical Evaluation Report (CER) Specialist / Medical Writer who will be responsible for clinical documentation required for Conformité Européene (CE) Mark following regulations and requirements set by the European Commission (EU MDR) and Notified Bodies. This is a one year contract opportunity.

The CER Specialist plays a key role in European registrations and introduction of new products/features through the contribution of clinical data and documentation.

Essential Duties And Responsibilities

• May author and/or critically review other clinical-regulatory documentation for all Accuray product lines, including responses to clinical questions from regulatory agencies and notified bodies.
• Plans, executes, and finalizes clinical deliverables for CE Mark of products under EU MDR, including authoring the Clinical Evaluation Plan (CEP) and the CER for all Accuray product lines.
• Authors literature search protocols and literature search reports.
• Compiles, appraises, and evaluates data from multiple sources including clinical studies, medical literature, design verification/validation data, and product complaint data.
• Contributes to project planning to assess the clinical requirements for global regulatory submissions, including determining when updates to the CER are required.
• Plans and conducts State of the Art and Safety/Performance literature reviews for the clinical evaluation of all Accuray product lines.
• Develops literature search strategies and conducts a methodical evaluation of medical literature.

Qualifications

• Skilled at using software such as MS word, referencing tools, SharePoint, document management systems.
• Expert understanding of systematic literature review (SLR) methodology and the requirements for the clinical evaluation of medical devices in accordance with the European Union Medical Devices Regulation (MDR) 2017/745/EC, MEDDEV 2.7/1 rev4 Clinical Evaluation: A Guide For Manufacturers And Notified Bodies, and IMDRF MDCE WG/N56FINAL:2019 Clinical Evaluation.
• Required
• Experience with radiation therapy products is a plus.
• An advanced degree in medical/science-related field (e.g., PhD, PharmD) is preferred.
• A degree (e.g., BS, MS, RN, etc.) in a scientific, biological or medical science discipline and/or regulatory discipline is required OR an equivalent of education and experience sufficient to successfully perform the essential functions of the job.
• Fluent in English.
• Can interpret, appraise, and analyze data and present results in tables, text, and graphs to facilitate understanding by the target audiences.
• Capable of performing literature searches in PubMed, EMBASE, and Google Scholar databases.
• Must have excellent communication skills to establish effective working relationships with different departments within Accuray (Regulatory, Marketing, Post Market, Quality, etc.)
• 3 years of experience in scientific / medical writing, with a strong record of accomplishment.
• Preferred or Desired
• Experience in writing MEDDEV 2.7.1 rev 4 and EU MDR compliant CERs for Class IIa or IIb medical devices.
• Must be able to effectively communicate scientific and regulatory information in a clear and lucid manner to the regulatory authorities.
• Be self-motivated and directed with the ability to manage time independently.

To qualify for this position, candidates must be able to furnish proof that they are authorized to work in the country they are applying on a permanent basis without sponsorship.

EEO Statement

At Accuray, our commitment to patient-first outcomes drives an inclusive and collaborative work environment where the best ideas rise to the top — and everyone works to push them further. We value diversity in both the professional and personal backgrounds of our employees, as this variety adds rich energy to every team, every project and every work day. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin – including individuals with disabilities and veterans.

Accuray Pay Transparency Statement

Accuray pay ranges vary based on work location. As a part of the total compensation package, this role may be eligible for the Accuray Bonus Plan or a role-specific commission/bonus, as well as annual refresh stock grants. Recruiters can share more detail during the hiring process. Each candidate’s compensation offer will be based on multiple factors including, but not limited to, geography, experience, skills, future potential and internal pay parity.