Job description

Our location in Plymouth, MN, or Santa Clara, CA currently has an opportunity for a Contract (Full time) Clinical Evaluation Reporting / Medical Writer (CER) (may be open to remote).

• The Medical Writer on our Regulatory Clinical Evaluation team provides technical and strategic writing expertise throughout the product development and life cycle process.
• Daily activities are related to authoring Clinical Evaluation Reporting documents for the Structural Heart and Vascular products.
• Experience in clinical study management and design, medical, or scientific writing, and/or quality engineering/risk management and strong written and verbal communication skills are needed.

WHAT YOU’LL DO

• Writes and contributes to Clinical Evaluation reporting deliverables such as Clinical Evaluation Plans/Reports, , SSCPs, Regulatory Responses and other related documentation.
• Evaluates and summarizes clinical evidence including data from sources such as clinical investigations, literature, post-market surveillance, risk, and post market clinical evaluations. Analyzes results in preparation for product applications and submissions.
• Collaborates with team members and stakeholders in planning for and supporting CER related projects and processes.
• Supports additional clinical, regulatory, quality and engineering related deliverable as assigned.
• Effectively communicates and collaborates with Sales and Marketing, R&D, Regulatory Affairs, Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs, Clinical Science, Risk Management and Medical Affairs in completing clinical evaluation project related deliverables.
• Maintains thorough knowledge of assigned products.
• Identifies appropriate sources of relevant data, interprets, evaluates and incorporates information from various sources including literature, clinical data, and medical references.
• Reviews IFUs, patient guides, Risk Management files, Clinical Evaluation Protocols, Clinical Evaluation Reports and Plans (CER/CEP), physician training materials, ensuring alignment of risk information. Involved in responses to complex queries such as those issued by notified bodies and stakeholders.
• Authors and contributes to necessary documents for regulatory submissions and communications, risk reviews and other processes such as regulatory inquiries.
• Ensures quality in all deliverables and documentation with attention to detail, consistency and integrity of data.
• Responsible for compliance with applicable corporate and divisional policies and procedures.
• Ensures compliance to applicable regulations and guidance’s (ISO13485, ISO14155, ISO14791, MEDDEV 2.7.1, MDR, and EU and FDA guidance documents) and applicable client SOPs and DOPs.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required

• Bachelor’s Degree or an equivalent combination of education and work experience
• 4-6 years of medical writing experience in the medical or pharmaceutical industry or 7+ years general technical writing experience required
• Experience may include writing experience in a medical, pharmaceutical, medical device, clinical research, medical or research industry , or combination of these skills
• CER writing experience required

Preferred

• Biomedical, sciences, medicine or similar health related discipline preferred
• Excellent written and verbal communication skills
• Experience with collaborative, cross-functional teams.
• Excellent analytical skills and ability to manage complex tasks and manage time effectively
• Proficient with Word, Excel, PowerPoint, Outlook, etc.

Job Type: Contract

Salary: $40.00 - $42.00 per hour

Schedule:

• 8 hour shift
• Day shift

Education:

• Bachelor's (Preferred)

Experience:

• CER medical writer: 4 years (Preferred)
• Clinical Evaluation Plans/Reports, , SSCPs: 3 years (Preferred)
• ISO13485, ISO14155, ISO14791, MEDDEV 2.7.1, MDR: 4 years (Preferred)
• medical device industry: 4 years (Preferred)

Work Location: Remote

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