Senior Engineering Program Manager, ServiceNow
Providence
Senior Clinical Evaluation Medical Writer
Medtronic
full-time
Posted on:
Origin: • 🇺🇸 United States • Massachusetts
Visit company websiteSalary
💰 $108,000 - $162,000 per year
Job Level
Senior
About the role
- Create and maintain Clinical Evaluation Reports (CER), Summary of Safety and Clinical Performance (SSCP) reports, Periodic Safety Update Reports (PSUR) and other regulatory clinical documents
- Write and edit manuscripts, abstracts, monographs, comprehensive reviews, scientific exhibits, and special summaries from raw data for regulatory submission or in-company use
- Conduct Post Market Surveillance activities including monthly literature review of product
- Proofreading, editing, document formatting, review comment integration and document completion/approval
- Collaborate with cross-functional team members daily and provide solution-oriented recommendations
- Administer applicable databases related to clinical data evaluation, Clinical Evaluation reports and Post Market surveillance reporting
- Create and manage project schedules for each clinical evidence document
- Compile, analyze, and summarize additional data from other sources as needed
- Prepare literature for new products and revise existing literature
- Support presentation, publication, and regulatory clinical document submission needs of assigned therapeutic areas
Requirements
- Bachelor’s Degree with a minimum of 4 years of medical or clinical writing experience OR a Master’s degree with 2 years of medical or clinical writing experience
- Nice to Have: Master’s or PhD degree(s) in biomedical sciences or technical disciplines
- Experience with medical and/or scientific writing within a medical device industry or related industry including preparation of Clinical Evaluation Reports and post market surveillance reporting
- Clinical research experience
- Experience creating and maintaining Clinical Evaluation Reports (CER), Summary of Safety and Clinical Performance report (SSCP) and Periodic Safety Update Reports (PSUR)
- Experience writing/editing manuscripts or abstracts on clinical studies and/or scientific reports
- Proofreading, editing, document formatting, review comment integration and document completion/approval experience
- Cross-functional collaboration skills and ability to provide solution-orientated recommendations
- Administration of applicable databases for clinical data evaluation and Post Market surveillance reporting
- Project scheduling and project management for clinical evidence documents
