Jobs via Dice
Job Title
Medical Writer II
Location Sunnyvale, CA 94043 (Hybrid)
Weekly Hours and Pay 30 hours per week, Pay Rate $70 on W2
Primary Function of Position Reports to the Manager, Medical Science and focuses on supporting the in‑house team with Clinical Evaluation Reports (CERs) for medical device products, helping to prepare for CE Mark applications, recertifications, and label changes under the Medical Device Regulation (MDR).
Roles and Responsibilities
Author clinical documentation sections of CERs.
Acquire knowledge of therapeutic areas and conduct literature reviews.
Perform comprehensive literature searches to support product lines and related clinical studies.
Work with the clinical librarian to search for product or product‑family information.
Review scientific literature, critically appraise data, and write clinical summaries.
Support global regulatory activities by meeting CER timelines and providing timely data.
Collaborate with internal teams to understand strategies for developing new and existing product CERs.
Conduct proofreading, editing, document formatting, and integrate review comments for approvals.
Assist in preparing clinical content such as manuscripts, abstracts, presentation slides, and posters based on clinical trials.
Potentially author study protocols and routine Clinical Study Progress Reports.
Ensure compliance with company SOPs and regulatory requirements.
Skill / Job Requirements
Minimum 2–4 years of medical writing experience; 0–2 years in device CER writing preferred.
Strong literature search, review, and critical appraisal skills.
Excellent verbal and written scientific communication abilities.
Excellent critical and analytical thinking with meticulous attention to detail.
Degree in a scientific field (MD, PhD, or MS) preferred.
Ability to manage multiple projects across various surgical disciplines.
Strong interpersonal skills and organizational capability.
Experience in protocol development and writing clinical sections for regulatory submissions.
Self‑starter attitude and ability to learn new surgical specialties quickly.
Dedication to meeting aggressive timelines and multiple projects as needed.
About IntelliPro Founded in 2009, IntelliPro is a global leader in talent acquisition and HR solutions, operating in over 160 countries. The company is committed to delivering unparalleled service, fostering employee growth, and building enduring partnerships across the globe.
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. We also accommodate candidates of all abilities throughout the hiring and interview processes.
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Location Sunnyvale, CA 94043 (Hybrid)
Weekly Hours and Pay 30 hours per week, Pay Rate $70 on W2
Primary Function of Position Reports to the Manager, Medical Science and focuses on supporting the in‑house team with Clinical Evaluation Reports (CERs) for medical device products, helping to prepare for CE Mark applications, recertifications, and label changes under the Medical Device Regulation (MDR).
Roles and Responsibilities
Author clinical documentation sections of CERs.
Acquire knowledge of therapeutic areas and conduct literature reviews.
Perform comprehensive literature searches to support product lines and related clinical studies.
Work with the clinical librarian to search for product or product‑family information.
Review scientific literature, critically appraise data, and write clinical summaries.
Support global regulatory activities by meeting CER timelines and providing timely data.
Collaborate with internal teams to understand strategies for developing new and existing product CERs.
Conduct proofreading, editing, document formatting, and integrate review comments for approvals.
Assist in preparing clinical content such as manuscripts, abstracts, presentation slides, and posters based on clinical trials.
Potentially author study protocols and routine Clinical Study Progress Reports.
Ensure compliance with company SOPs and regulatory requirements.
Skill / Job Requirements
Minimum 2–4 years of medical writing experience; 0–2 years in device CER writing preferred.
Strong literature search, review, and critical appraisal skills.
Excellent verbal and written scientific communication abilities.
Excellent critical and analytical thinking with meticulous attention to detail.
Degree in a scientific field (MD, PhD, or MS) preferred.
Ability to manage multiple projects across various surgical disciplines.
Strong interpersonal skills and organizational capability.
Experience in protocol development and writing clinical sections for regulatory submissions.
Self‑starter attitude and ability to learn new surgical specialties quickly.
Dedication to meeting aggressive timelines and multiple projects as needed.
About IntelliPro Founded in 2009, IntelliPro is a global leader in talent acquisition and HR solutions, operating in over 160 countries. The company is committed to delivering unparalleled service, fostering employee growth, and building enduring partnerships across the globe.
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. We also accommodate candidates of all abilities throughout the hiring and interview processes.
#J-18808-Ljbffr