Medical Writer IV
Prokatchers
Job Summary Medical Writer IV
- Position: Clinical Evaluation Reporting / Medical Writer (CER)
- Location: On-site at Santa Clara, CA, St. Paul, MN, Maple Grove, MN, Plano, TX,
Key Responsibilities:
- Write and contribute to Clinical Evaluation documents (CERs, CEPs, SSCPs, Regulatory Responses, etc.) for vascular products.
- Evaluate and summarize clinical evidence from various sources (clinical investigations, literature, post-market surveillance, etc.).
- Analyze data for product applications and regulatory submissions.
- Collaborate with cross-functional teams (Regulatory, Quality, Engineering, Clinical, Marketing, etc.) to support CER projects.
- Maintain thorough knowledge of assigned products and identify relevant data sources.
- Review and align documentation (IFUs, risk management files, CERs, PMS/PMCF plans, training materials) with risk information.
- Respond to complex regulatory queries from notified bodies and stakeholders.
- Ensure quality, consistency, and compliance of all deliverables with applicable regulations (ISO, MDR, FDA, etc.) and procedures.
- Support additional clinical, regulatory, quality, and engineering deliverables as assigned.
Requirements:
- Bachelor's Degree or equivalent combination of education and experience.
- 6-8 years of medical writing experience in medical, pharmaceutical, or related industries (or 8+ years technical writing).
- Experience in clinical study management/design, medical/scientific writing, or quality engineering/risk management.
- Excellent written and verbal communication skills.
- Strong analytical, organizational, and time management abilities.
- Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
Preferred:
- Degree in biomedical, science, medicine, or related discipline.
- Experience specifically with CER writing.
- Experience with cross-functional and collaborative teams.
- Position: Clinical Evaluation Reporting / Medical Writer (CER)
- Location: On-site at Santa Clara, CA, St. Paul, MN, Maple Grove, MN, Plano, TX,
Key Responsibilities:
- Write and contribute to Clinical Evaluation documents (CERs, CEPs, SSCPs, Regulatory Responses, etc.) for vascular products.
- Evaluate and summarize clinical evidence from various sources (clinical investigations, literature, post-market surveillance, etc.).
- Analyze data for product applications and regulatory submissions.
- Collaborate with cross-functional teams (Regulatory, Quality, Engineering, Clinical, Marketing, etc.) to support CER projects.
- Maintain thorough knowledge of assigned products and identify relevant data sources.
- Review and align documentation (IFUs, risk management files, CERs, PMS/PMCF plans, training materials) with risk information.
- Respond to complex regulatory queries from notified bodies and stakeholders.
- Ensure quality, consistency, and compliance of all deliverables with applicable regulations (ISO, MDR, FDA, etc.) and procedures.
- Support additional clinical, regulatory, quality, and engineering deliverables as assigned.
Requirements:
- Bachelor's Degree or equivalent combination of education and experience.
- 6-8 years of medical writing experience in medical, pharmaceutical, or related industries (or 8+ years technical writing).
- Experience in clinical study management/design, medical/scientific writing, or quality engineering/risk management.
- Excellent written and verbal communication skills.
- Strong analytical, organizational, and time management abilities.
- Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
Preferred:
- Degree in biomedical, science, medicine, or related discipline.
- Experience specifically with CER writing.
- Experience with cross-functional and collaborative teams.
Vacancy posted 1 day ago
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