Education & Experience:

• Bachelor’s Degree required in a related field
• Minimum of 2 years medical writing experience in the medical or pharmaceutical industry or 5 years general technical writing experience required
• Experience may include writing experience in a medical, pharmaceutical, medical device, clinical research, medical or research industry, or a combination of these skills
• PSUR writing experience strongly preferred
• Literature search experience is preferred
• Biomedical, sciences, medicine or similar health related disciplines preferred

Qualifications:

• 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.
• High level of attention to detail
• Ability to prioritize key business objectives and respond quickly to changing priorities
• Ability to work independently with minimal daily instruction
• Able to multitask and work in a fast-paced environment

Travel Requirements

• Typically requires travel less than 5% of the time

 Responsibilities:

• Writes and contributes to Clinical Evaluation reporting deliverables including Post-Market Surveillance Plans and Periodic Safety Update Reports (PSURs), 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 regulatory submissions and the maintenance of clinical evaluation report files.
• Collaborates with team members and stakeholders in planning for and supporting PSUR related projects and processes.
• Supports additional clinical, regulatory, quality and engineering related deliverables as assigned.
• Effectively communicates and collaborates with Sales and Marketing, R&D, Regulatory Affairs, Quality Engineering, 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 Reports and Plans (CER/CEP), clinician 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 to regulatory submissions and communications, 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.