Medical Writer (Hybrid - Sunnyvale, CA)

***Please note that our customer is currently not considering applicants from the following locations: Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, and Tennessee.***

Our Customer is a corporation that develops, manufactures, and markets robotic products designed to improve clinical outcomes of patients through minimally invasive surgery. Founded in 1995, their goal was to create innovative, robotic-assisted systems that help empower doctors and hospitals to make surgery less invasive than an open approach. Working with the top medical professionals, they continue to develop new, minimally invasive surgical platforms and future diagnostic tools to help solve complex healthcare challenges around the world.

We are seeking a Medical Writer on a contract basis to support our Customer's business needs. This role is hybrid in Sunnyvale, CA

This role will support the development of clinical regulatory documents, with a primary focus on authoring Clinical Evaluation Reports (CERs) in compliance with Medical Device Regulation (MDR). The role contributes to meeting essential requirements for CE Mark applications, market clearance, recertification, and labeling changes. This position requires strong medical writing skills, attention to detail, and the ability to collaborate cross-functionally within clinical and regulatory teams.

Part-time, 30 hours/week

Responsibilities:

• Author sections of clinical documentation as part of Clinical Evaluation Reports (CERs).
• Acquire in-depth knowledge of therapeutic areas and conduct comprehensive literature reviews.
• Perform literature searches and critically appraise scientific data to support clinical summaries for products and surgical procedures.
• Collaborate with internal teams to align on strategy and development timelines for new and existing products.
• Ensure adherence to CER timelines and provide data to support global regulatory activities.
• Conduct proofreading, editing, document formatting, review comment integration, and final document approval activities.
• Assist in the creation of clinical content such as manuscripts, abstracts, presentations, and posters based on clinical trials.
• Author clinical protocols and routine clinical study progress reports as needed.
• Ensure compliance with corporate procedures (SOPs) and regulatory requirements (GCP, U.S., and international guidelines).

Skills and Qualifications:

• Advanced degree (MD, PhD, or MS) in a scientific or medical field preferred.
• 2-4 years of experience in medical writing within a clinical or regulatory environment.
• 0-2 years of experience in clinical evaluation report writing in the medical device industry preferred.
• Strong background in conducting literature searches, reviews, and data appraisal.
• Proven ability to write clear, concise, and accurate scientific or technical documentation.
• Excellent analytical and critical thinking skills.
• Strong attention to detail, organization, and accuracy.
• Ability to manage multiple projects across various surgical disciplines.
• Effective communication, presentation, and interpersonal skills.
• Experience in protocol development and writing clinical sections for regulatory submissions.
• Self-starter with the ability to learn quickly and adapt to new surgical specialties.
• Demonstrated commitment to meeting tight deadlines and managing concurrent projects.

We offer a competitive salary range for this position. Most candidates who join our team are hired at the median of this range, ensuring fair and equitable compensation based on experience and qualifications.

Contractor benefits are available through our 3rd Party Employer of Record (Available upon completion of waiting period for eligible engagements) Benefits include: Medical, Dental, Vision, 401k.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.