Job Description
Job Title: Medical Writer II Location: Sunnyvale, CA 94043 (Hybrid) Weekly work hours: 30 Pay Rate: $70 on W2 Primary Function of Position: This position reports to Manager, Medical Science and requires a strong candidate with experience in medical writing of clinical regulatory documents. The position will mainly focus supporting the inhouse team with the 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/labelling changes, as well as CER updates to maintain EU product conformance.
Roles and Responsibilities: - This position has responsibility and authority for:
- 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 our clinical trials.
- May author Protocols and/or routine Clinical Study Progress Reports.
- Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and US and OUS guidelines)
Skill/Job Requirements: - Competency Requirements: (Competency is based on: Education, training, skills, and experience.)
- 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 communicate verbally clearly and effectively 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
About Us: Founded in 2009, IntelliPro is a global leader in talent acquisition and HR solutions. Our commitment to delivering unparalleled service to clients, fostering employee growth, and building enduring partnerships sets us apart. We continue leading global talent solutions with a dynamic presence in over 160 countries, including the USA, China, Canada, Singapore, Japan, Philippines, UK, India, Netherlands, and the EU.
IntelliPro, a global leader connecting individuals with rewarding employment opportunities, is dedicated to understanding your career aspirations. As an Equal Opportunity Employer, IntelliPro values diversity and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, disability, or any other legally protected group status. Moreover, our Inclusivity Commitment emphasizes embracing candidates of all abilities and ensures that our hiring and interview processes accommodate the needs of all applicants. Learn more about our commitment to diversity and inclusivity at .
Compensation: The pay offered to a successful candidate will be determined by various factors, including education, work experience, location, job responsibilities, certifications, and more. Additionally, IntelliPro provides a comprehensive benefits package, all subject to eligibility.
Job Tags
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