Senior Medical Writer
We believe that great healthcare is an essential safeguard of human dignity.
At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you.
We support and empower our employees to grow their careers in an environment that encourages a sense of belonging and a connection to doing good. We’re not afraid to roll up our sleeves to make our goals a reality and work together to solve for our customers. We reward and recognize our employees based on our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion.
Who We’re Looking For:
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.
About the Role:
- 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.
Minimum Qualifications:
- 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
Preferred Qualifications:
- Experience working in field of medical devices
- Experience in biostatistical analysis, interpretation and data collection techniques
- Project Management experience
Why Laborie:
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.
- 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
Laborie provides equal employment opportunities 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.