Medical Writer II

System One; Sunnyvale (CA); Remote; USD 111,751,000 - 131,092,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Spending accounts

Life insurance

Voluntary plans

401(k) plan

Job summary

System One is seeking a Medical Writer II to support Clinical Evaluation Reports under MDR for CE marking. This remote contract role (12 months, renewable) is part-time up to 30 hours with compensation $52-$61/hr, located in Sunnyvale, CA.

You will write CER sections, perform literature reviews, and ensure regulatory compliance. Ideal candidates have 2–4 years medical writing experience, a relevant scientific degree, and strong communication skills.

Qualifications

• Minimum 2–4 years medical writing experience in a regulated environment.
• Experience in clinical evaluation reports (CER) writing preferred.
• Strong ability to search, review, and appraise scientific literature.
• Excellent scientific writing and communication skills.
• Attention to detail and ability to manage multiple projects.

Responsibilities

• Author CER sections and perform literature searches to support product lines.
• Review literature and write clinical summaries for products and procedures.
• Collaborate with internal teams for CER timelines and regulatory activities.
• Proofread, edit, format documents, and integrate reviewer comments.
• Assist with manuscripts, abstracts, conference posters based on trials.
• Develop protocols and/or routine Clinical Study Progress Reports.
• Ensure compliance with SOPs, GCP, and regulatory guidelines.

Skills

Literature searches

Scientific writing

Communication skills

Attention to detail

Regulatory knowledge

Multitasking

Team collaboration

Education

MD, PhD or MS in scientific field

Job description

Job Title: Medical Writer II
Location: Sunnyvale, CA
Type: Contract (12 months - renewable)
Compensation: $52-$61hr (based on location)
Work Model: remote
Hours: Part time - Up to 30 hours

Overview

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.

Responsibilities

• 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 company clinical trials.
• May author Protocols and/or routine Clinical Study Progress Reports.
• Ensures compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and US and OUS guidelines

Requirements

• Previous experience in the application of therapeutic and device knowledge to support the development of clinical evaluation reports.
• Must have a 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; demonstrated effective scientific writing skills.
• Excellent critical and analytical thinking skills.
• MD, PhD or M.S. degree in scientific field is desired.
• Must have high level of attention to detail and accuracy.
• Must be able to work effectively with internal team members.
• Must be able 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 section 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

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

Benefits

• medical
• dental
• vision
• spending accounts
• life insurance
• voluntary plans
• participation in a 401(k) plan

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Ref: #558-Scientific