Senior Medical Writer
TalentBurst, an Inc 5000 company, Santa Clara, CA, United States
Duration: 6-12 months from the start date of the worker with possibility to extend contract
Location: St. Paul, MN; Santa Clara, CA; or remote
Onsite or Remote Role-
Schedule: 8 to 5 in respective time zone; if not in PST time zone, occasional meetings after 5 pm might be required.
Top 3 Skills or Any Specific type of Experience you are looking for:
Experience writing Medical Device MDR compliant CERs, CEPs and SSCPs
Vascular or other medical device experience such as Clinical Study
Education: A bachelor's degree is required along with 6-8 years of experience.
Role Overview: We are currently seeking a Clinical Evaluation Reporting (CER) / Medical Writer specializing in vascular medical devices. This role is part of the Regulatory Clinical Evaluation team and involves providing both technical and strategic writing support throughout the product development lifecycle.
The primary responsibility is the development of Clinical Evaluation Reports and related documentation for vascular products. The ideal candidate will have experience in clinical study design and management, scientific or medical writing, and/or quality engineering or risk management, along with strong communication skills.
Key Responsibilities:
Author and contribute to Clinical Evaluation documentation, including Plans/Reports (CER/CEP), PMS and PMCF Plans/Reports, SSCPs, and regulatory responses
Review, evaluate, and summarize clinical data from sources such as clinical trials, published literature, post-market surveillance, and risk assessments
Analyze data to support regulatory submissions and product approvals
Collaborate with internal teams and stakeholders to plan and execute CER-related projects
Support additional deliverables across clinical, regulatory, quality, and engineering functions as needed
Work closely with cross-functional teams including Sales & Marketing, R&D, Regulatory Affairs, Clinical Affairs, Quality Engineering, Risk Management, and Medical Affairs
Maintain in-depth knowledge of assigned products and identify relevant data sources for evaluation
Review and ensure alignment across documents such as IFUs, patient guides, risk management files, and training materials
Contribute to responses for regulatory queries and notified body questions
Prepare documentation for regulatory submissions, risk assessments, and compliance processes
Ensure high-quality, accurate, and consistent documentation aligned with internal standards and regulatory requirements
Maintain compliance with applicable regulations and standards such as ISO 13485, ISO 14155, ISO 14971, MEDDEV 2.7.1, MDR, and FDA/EU guidelines
Education and Experience: Required:
Bachelor's degree or equivalent practical experience
6–8 years of medical writing experience in healthcare/pharmaceutical industries or 8+ years in technical writing
Experience across medical, pharmaceutical, medical device, or clinical research domains
Preferred:
Degree in biomedical sciences, medicine, or a related field
CER writing experience
Strong communication and interpersonal skills
Experience working in cross-functional teams
Strong analytical and multitasking capabilities with effective time management
Proficiency in Microsoft Office tools (Word, Excel, PowerPoint, Outlook
#J-18808-Ljbffr
Experience writing Medical Device MDR compliant CERs, CEPs and SSCPs
Vascular or other medical device experience such as Clinical Study
Education: A bachelor's degree is required along with 6-8 years of experience.
Role Overview: We are currently seeking a Clinical Evaluation Reporting (CER) / Medical Writer specializing in vascular medical devices. This role is part of the Regulatory Clinical Evaluation team and involves providing both technical and strategic writing support throughout the product development lifecycle.
The primary responsibility is the development of Clinical Evaluation Reports and related documentation for vascular products. The ideal candidate will have experience in clinical study design and management, scientific or medical writing, and/or quality engineering or risk management, along with strong communication skills.
Key Responsibilities:
Author and contribute to Clinical Evaluation documentation, including Plans/Reports (CER/CEP), PMS and PMCF Plans/Reports, SSCPs, and regulatory responses
Review, evaluate, and summarize clinical data from sources such as clinical trials, published literature, post-market surveillance, and risk assessments
Analyze data to support regulatory submissions and product approvals
Collaborate with internal teams and stakeholders to plan and execute CER-related projects
Support additional deliverables across clinical, regulatory, quality, and engineering functions as needed
Work closely with cross-functional teams including Sales & Marketing, R&D, Regulatory Affairs, Clinical Affairs, Quality Engineering, Risk Management, and Medical Affairs
Maintain in-depth knowledge of assigned products and identify relevant data sources for evaluation
Review and ensure alignment across documents such as IFUs, patient guides, risk management files, and training materials
Contribute to responses for regulatory queries and notified body questions
Prepare documentation for regulatory submissions, risk assessments, and compliance processes
Ensure high-quality, accurate, and consistent documentation aligned with internal standards and regulatory requirements
Maintain compliance with applicable regulations and standards such as ISO 13485, ISO 14155, ISO 14971, MEDDEV 2.7.1, MDR, and FDA/EU guidelines
Education and Experience: Required:
Bachelor's degree or equivalent practical experience
6–8 years of medical writing experience in healthcare/pharmaceutical industries or 8+ years in technical writing
Experience across medical, pharmaceutical, medical device, or clinical research domains
Preferred:
Degree in biomedical sciences, medicine, or a related field
CER writing experience
Strong communication and interpersonal skills
Experience working in cross-functional teams
Strong analytical and multitasking capabilities with effective time management
Proficiency in Microsoft Office tools (Word, Excel, PowerPoint, Outlook
#J-18808-Ljbffr