Senior Medical Writer Position
Contract Hire – Minneapolis, MN
The Senior Medical Writer will be responsible for developing, writing, and/or completing clinical/regulatory documents, e.g. Clinical Evaluation Reports (CERs) and Clinical Evaluation Plan for a variety of clients. The Senior Medical Writer will utilize clinical data, published literature, clinical investigation results, and field performance data in order to evaluate the product safety and performance. The Senior Medical Writer has extensive experience and understanding in clinical research and regulatory guidelines.
Essential Duties and Responsibilities:
- Provide scientific and/or medical expertise, analytical thought processes and a robust, systematic clinical evaluation approach in order to continuously collect, analyze and assess clinical data.
- Plan, develop and prepare CERs and related evidence deliverables (Clinical Evaluation Plans, Post-market Clinical Follow-up (PMCF) Plans, and others) for medical devices in compliance with client SOPs, templates and applicable clinical and regulatory standards.
- Analyze pre-clinical data, risk management assessments, published literature, clinical investigation results and field performance data in order to evaluate product safety and performance. Identify and resolve questions related to this data.
- Analyze and document data from clinical publications.
- Develop and implement literature searches related to various products/product families. Use of EndNote or comparable citation management software preferred.
- Ensure compliance client specific SOPs and all related regulatory requirements.
- Ability to mentor junior or entry level medical writers.
- Conduct proofreading, editing, document formatting, review comment integration and document completion/approval activities. Use of PerfectIt preferred.
- Ability to work independently with minimal supervision.
- Other duties as assigned by management.
- Advanced Degree in biological or medical science is required or equivalent education and experience with demonstrated ability to perform the essential functions of the job may be considered.
- Minimum 5 years technical or CER writing experience within the medical device industry is preferred.
- Familiarity with current regulatory agency guidance and regulations, including FDA, EU MDR and MEDDEV 2.7/1 Rev 4.
- Demonstrated writing capability and critique of clinical and regulatory documentation.
- Expert level knowledge of Microsoft Office products, in particular Word.
- Proficient in citation manager software, e.g. EndNote.
- Ability to work remotely.
- Excellent communication and interpersonal skills, ability to establish and maintain effective communication with colleagues and clients. Ability to resolve conflicts and move teams toward resolutions and solutions.
- Previous experience in the application of in-depth therapeutic and device knowledge to development of CERs preferred.
- Proficient knowledge and understanding of medical terminology, clinical practices, physiology and/or applicable disease states.
- Excellent time management skills.