Medical Writer IV

What You’ll Do

• Writes and contributes to Clinical Evaluation reporting deliverables including Clinical Evaluation Plans/Reports, PMS and PMCF 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.
• Involves 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 SOPs and DOPs.

Requirements

• Required Bachelor’s Degree or an equivalent combination of education and work experience
• 6-8 years of medical writing experience in the medical or pharmaceutical industry or 8+ 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
• PREFERRED: Biomedical, sciences, medicine or similar health related discipline preferred
• CER writing experience 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.