[Hiring] Medical Writer 2 @Intuitive Surgical

Role Description

This position reports to the Manager, Medical Science and requires a strong candidate with experience in medical writing of clinical regulatory documents. The position will mainly focus on supporting the in-house team with the Clinical Evaluation Reports (CERs), with potential for future additional responsibility for the development of other clinical evidence documents.

The purpose of this job is to support clinical evaluation reports (CERs) per Medical Device Regulation (MDR), to meet essential requirements in support of submission for CE Mark application to obtain Declaration of Conformity and EU market clearance, recertification, and proposed indication/labeling changes, as well as CER updates to maintain EU product conformance.

• Authoring sections of Clinical documentation as part of the Clinical Evaluation Reports (CER).
• Acquire knowledge of therapeutic areas, literature review processes, and the ability to keep abreast of current literature.
• Participates in and/or performs comprehensive literature searches to develop in-depth knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies.
• Work with the clinical librarian to help with conducting literature searches on products/product families.
• Review the scientific literature and critically appraise and write clinical summaries for products and surgical procedures.
• Support the internal team members by adhering to CER timelines and providing data in a timely manner to support global Regulatory activities.
• Interacting with internal teams to understand the plan and strategy for development of the Clinical evaluation reports for new and existing products.
• Conduct proofreading, editing, document formatting, review comment integration, and document completion/approval activities.
• May assist with creation of clinical content including the preparation of manuscripts, scientific abstracts, conference presentations, and posters based on client clinical trials.
• May author Protocols and/or routine Clinical Study Progress Reports.
• Ensure compliance with corporate (e.g., SOPs) and regulatory requirements (e.g., GCP and US and OUS guidelines).

Qualifications

• Previous experience in the application of therapeutic and device knowledge to support the development of clinical evaluation reports.
• Minimum of 2-4 years of medical writing experience.
• Minimum of 0-2 years of experience in clinical evaluation report writing in a medical device industry is preferred.
• Strong experience in conducting literature searches, reviews, and appraisal of the scientific data.
• Demonstrated ability to clearly and effectively communicate verbally and in technical or scientific writing.
• Excellent critical and analytical thinking skills.
• MD, PhD, or M.S. degree in a scientific field is desired.
• High level of attention to detail and accuracy.
• Ability to work effectively with internal team members.
• Ability to manage multiple projects across numerous surgical disciplines.
• Strong communication, presentation, and interpersonal skills with high attention to detail and organization.
• Strong experience in protocol development and writing clinical sections for regulatory submission.
• Ability to learn quickly and self-educate on different surgical specialties as applicable to medical products and procedures (Self-starter attitude).
• Consistently shows dedication or strong work ethic to help meet aggressive timelines or multiple projects when necessary.

Benefits

• Competitive compensation.
• Comprehensive benefits, including medical, dental, vision, and retirement options.

Company Description

At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long-term growth.

Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.