Senior Change Management Lead

System One; Sunnyvale (CA); Remote; USD 179,000 - 193,000; Full time

Job summary

System One, Inc. is seeking a Senior Change Management Lead on a remote contract basis in Sunnyvale, CA. The role focuses on supporting Clinical Evaluation Reports under MDR to assist CE marking and regulatory submissions.

The ideal candidate will have 2–4 years medical writing experience, CER writing in medical devices, and strong literature review and scientific writing capabilities, with excellent communication and project management skills.

Qualifications

• Minimum 2–4 years of medical writing experience.
• 0–2 years of CER writing experience in medical device industry preferred.
• Strong experience in literature searches, reviews and data appraisal of scientific data.
• Excellent scientific writing and communication skills.
• High attention to detail with ability to manage multiple projects.

Responsibilities

• Author CER sections and perform literature searches.
• Review the literature and write clinical summaries for products and procedures.
• Support global Regulatory activities with timely data submissions.
• Collaborate with internal teams on CER development plans.
• Proofread, edit, format, and incorporate review comments.
• Assist with manuscript preparation including abstracts and posters.
• Possibly author protocols and routine Clinical Study Progress Reports.
• Ensure compliance with SOPs and regulatory guidelines (GCP, US and OUS).

Skills

Medical writing

Literature review

Regulatory submissions

Clinical evaluation reports

Communication skills

Data analysis

Education

MD/PhD/MS

Tools

MS Word

EndNote

PubMed

Job description

Job Title: Senior Change Management Lead
Location: Sunnyvale, CA
Type: Contract
Compensation: $130-$140/hr
Work Model: Remote
Hours: 40 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 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.

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