Jobs via Dice is hiring: Medical Writer 2 in Sunnyvale

Medical Writer 2

Primary Function of Position:

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 Clinical Evaluation Reports (CERs), with potential for future additional responsibility for 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.

Roles and Responsibilities

• Author sections of Clinical documentation as part of the Clinical Evaluation Reports (CER).
• Acquire knowledge of therapeutic areas, literature review processes and keep abreast of current literature.
• Participate in and/or perform comprehensive literature searches to develop in‑depth knowledge of current scientific literature required to support identified product lines and related clinical studies.
• Work with the clinical librarian to assist with conducting literature searches on products/product families.
• Review 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.
• Interact with internal teams to understand the plan and strategy for development of Clinical Evaluation Reports for new and existing products.
• Conduct proofreading, editing, document formatting, review comment integration and document completion/approval activities.
• Assist with creation of clinical content including preparation of manuscripts, scientific abstracts, conference presentations and posters based on intuitive clinical trials.
• May author Protocols and/or routine Clinical Study Progress Reports.
• Ensure compliance with corporate SOPs and regulatory requirements.

Skill/Job Requirements

• 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.
• Preferred: 0–2 years of experience in clinical evaluation report writing in a medical device industry.
• Strong experience in conducting literature searches, reviews, and appraisal of 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 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.
• Consistently shows dedication or strong work ethic to meet aggressive timelines or multiple projects when necessary.

We are an AA/EEO/Veterans/Disabled employer.