Medical Writer Jobs

We believe that great healthcare is an essential safeguard of human dignity.

Our Mission every day is to operate as a world-class specialist medical company making and advancing technologies that preserve and restore human dignity. We do that today by helping people with pelvic and gastrointestinal conditions live normal lives, and by helping mothers and babies have safe deliveries.

If you share our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion, and are looking to contribute and grow in a fast-paced environment, join us to enhance our customer experience with dignity, at the heart of everything.

Laborie Medical Technologies is currently searching for a Medical Writer to join our team in Minnetonka, MN on a hybrid basis (1-2 days/week)

Position Overview:

The Medical Writer collaborates in the development and execution of clinical, scientific, and regulatory documents and presentations for internal support, global regulatory agencies, 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 reports and plans, clinical study protocols and reports, abstracts and manuscripts for clinical and scientific content and may assist with the development of instructions for use and other product labeling that requires the presentation of medical information.

How you contribute:

• Provide scientific guidance and support to the internal teams in development of the publication strategy and marketing claims
• Assist in ensuring all clinical requirements are met for device registrations and maintenance while working with other Laborie team members
• 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
• Performs on-line literature searches, write literature reports, 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 towards the creation of appropriate device claims, indications, publications, and clinical evaluation reports (CER) and Clinical Study Reports (CSRs)

• Undertake various projects and tasks as assigned

Qualifications:

• Advanced degree in mechanical engineering, micro engineering or similar

• Bachelor's degree in a scientific field or in a writing/composition discipline
• Experience in Clinical Evaluation Reports or similar technical documentation
• Expertise in conducting focused literature searches on PubMed, Embase, Google Scholar and/or other similar medical literature databases
• 2+ years of experience in medical or technical writing

• Working knowledge of medical device clinical regulations preferred (ISO, MEDDEV, MDR, FDA CFR).
• Experience working in field of medical devices

• Strong computer skills and proficient in MS Office Suite.
• Ability to work both independently and collaboratively in a team setting.
• Excellent English verbal and written communication skills with great attention to detail.
• Experience in biostatistical analysis, interpretation and data collection techniques preferred.

How we take care of you:

• Health Savings Account and Flexible Spending Account
• Flexible work schedule and environment
• Medical, Dental, Vision, and Employee Wellbeing programs
• Paid holidays
• Paid time off and Volunteer time
• Parental Leave and Adoption Services
• Company-paid short-term and long-term disability and Basic Life and AD&D
• 401k Retirement Plan with Company Match

Laborie is a specialty manufacturer and supplier of medical technologies and devices, committed to excellence in diagnostics and therapeutics for Urological, Gastrointestinal, Obstetric, Gynecological, and Neonatal healthcare and committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Laborie is committed to providing access and reasonable accommodation in our services, activities, education and employment for individuals with disabilities.

www.laborie.com