Medical Writer II
About The Position
The Medical Writer II collaborates in the development and execution of clinical, scientific, and regulatory documents and presentations for internal support, global regulatory agencies, and scientific conferences and meetings. This involves collaboration with internal and external partners to support technical, medical, and clinical writing functions for Clinical and Regulatory business needs in accordance with the relevant standards as well as LABORIE standard operating procedures. This person will write a variety of documents for distinct audiences including Post-Market Surveillance plans and reports, clinical evaluation plans and reports, reports and study protocols, and may assist with the development of instructions for use and other product labeling that requires the presentation of medical information.
Requirements
- Bachelor's degree in a scientific field or in writing/composition discipline and 5+ years' experience in medical or technical writing.
- Experience in 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, IVDR, FDA CFR) and experience 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 in MS Office and ability to work both independently and collaboratively in a team setting.
- Excellent English verbal and written presentation skills, with great attention to detail.
Nice To Haves
- Experience working in the medical device industry preferred.
- Project Management experience preferred.
Responsibilities
- Performs online literature searches, manage the literature database, and prepare literature reviews to support LABORIE's products.
- Critically appraise, analyze, and summarize data from experiments, clinical trials, and publications in the support of appropriate device claims, indications, publications, and clinical evaluation reports (CERs) 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.
- Research, create, and edit scientific documents and presentations to and from the internal team, KOLs, investigators, and physicians.
- Assist in ensuring all clinical requirements are met for device registrations and maintenance while working with other LABORIE team members.
- Undertake various projects and tasks as assigned.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
