Senior Medical Writer
As a key member of our Clinical Research team, the Senior Medical Writer will collaborate with internal and external partners in the development and execution of clinical, scientific, and regulatory documents and presentations for internal support, global regulatory agencies, scientific conferences and meetings. Role will support technical, medical, and clinical writing functions for Clinical and Regulatory business needs in accordance with relevant standards as well as Laborie standard operating procedures. The Senior Medical Writer will be responsible for writing a variety of documents for distinct audiences including post market surveillance plans and reports, clinical evaluation reports and plans, clinical study protocols and reports, abstracts and manuscripts for clinical and scientific content and may assist in the development and instruction for use and other product labeling that requires the presentation of medical information.
- Independently perform on-line literature searches, write literature reports, manage literature database and prepare literature reviews to support Laborie products.
- Critically appraise, analyze, and summarize data from experiments, clinical trials, and publications towards the creation of appropriate device claims, indications, publications and clinical evaluation reports (CER) and Clinical Study Reports (CSRs).
- Search out, review, write and maintain records of post market surveillance (PMS) data pertaining to the safety and effectiveness of Laborie devices and support development of Clinical timelines of assigned products and clinical evaluation deliverables in conjunction with the PMS Project Coordinator.
- Research, create and edit scientific documents and presentations to and from the internal team, KOLs investigators and physicians.
- Provide scientific guidance and support to the internal teams in development of publication strategy and marketing claims; assist in ensuring all clinical requirements are met for device registrations and maintenance while working with Laborie team members.
- Participate in and/or lead the development of regulatory responses for Notified Body questions upon review of submissions.
- Clearly and timely communicate the timelines, project risks, and risk mitigation strategies with cross functional teams for assigned projects.
- Bachelor's degree in a scientific field or in writing/composition discipline and 8+ years' experience in medical or technical writing
- Experience in writing Clinical Evaluation Reports and similar technical documentation in accordance with MEDDEV 2.7/1 Rev 4 and MDR Submissions
- Working knowledge of medical device clinical regulations, standards and guidelines (ISO, MEDDEV, MDR, FDA CFR) and expertise in conducting focused literature searches on PubMed, Embase, Google Scholar or other similar medical literature databases
- Demonstrated ability to manage project timelines, including ability to adapt to shifting priorities and competing demands while maintaining strong attention to detail
- Strong computer skills, proficiency with MS Office and ability to work both independently and collaboratively in a team setting
- Excellent English verbal, written and presentation skills with great attention to detail
- Experience working in field of medical devices
- Experience in biostatistical analysis, interpretation and data collection techniques
- Project Management experience
- Paid time off and paid volunteer time
- Medical, Dental, Vision and Flexible Spending Account
- Health Savings Account with Company Funded Contributions
- 401k Retirement Plan with Company Match
- Parental Leave and Adoption Services
- Health and Wellness Programs and Events
- Awarded 2023 Cigna Healthy Workforce Designation Gold Level
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Founded in 1967, Laborie manufactures and supplies pelvic health and gastrointestinal equipment and consumables for urodynamic testing. Laborie is located in Canada.
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