Medical Writer II

Laborie; Minnetonka (MN); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Paid time off

Pension Plan

Parental Leave

Health and Wellness Programs

Job summary

Laborie is seeking a Medical Writer II to develop clinical, scientific, and regulatory documents for global agencies. This role collaborates with partners to support PMS plans, PSURs and PMCFERs while ensuring compliance with evolving international standards.

The candidate will manage PMS data reviews, summarize data, and help integrate PMS activities into regulatory reports across multiple regions.

Qualifications

• Bachelor's degree in a scientific field or writing discipline.
• 5+ years' experience writing PSURs in medical writing.
• Working knowledge of medical device regulatory standards and guidelines.

Responsibilities

• Collaborate on clinical, scientific and regulatory documents for global agencies.
• Write PSURs, CERs, PMCFERs and PMS related reports as required.
• Review internal/external data and support PMS programs across geographies.
• Maintain PMS data records and ensure alignment with regulatory requirements.
• Work cross-functionally to integrate PMS findings into regulatory submissions.

Skills

Medical writing

PSUR writing

Regulatory knowledge

English communication

Education

Bachelor's degree in a scientific field

Tools

MS Office

Job description

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:

The Medical Writer II collaborates in the development and execution of clinical, scientific, and regulatory documents for global regulatory agencies. This involves collaboration with internal and external partners to support technical, medical and clinical writing outputs for Clinical and Regulatory business needs in accordance with the relevant and evolving international standards as well as LABORIE standard operating procedures. This person will write a variety of documents for distinct audiences including Post-Market Surveillance (PMS) plans, PMS reports, Periodic Safety Update Reports (PSURs) and Proactive PMS study protocols, and will contribute to Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-Up Reports (PMCFERs).

About the Role:

• Perform on-line external vigilance reviews and compare results to the Risk Management File.
• Critically appraise, analyze, and summarize internal and external data in support of the PMS requirements for geographies such as the EU, Health Canada, UK, etc.
• Search out, review, write and maintain records of PMS data pertaining to the safety and effectiveness of Laborie devices.
• Assist in ensuring all PMS requirements are met for device registrations and maintenance while working with other LABORIE team members.
• Work cross functionally to develop, compile and report proactive PMS activities and integrate reporting into PMCFERs and PSURs.
• Undertake various projects and tasks as assigned.

What you Bring:

• Bachelor's degree in a scientific field or in writing/composition discipline and 5+years' experience writing PSURs. Experience with Medical Writing required.
• Working knowledge of medical device clinical and PMS regulations, standards and guidelines (ISO, MEDDEV, MDR, IVDR, FDA CFR, UKCA, Health Canada) and experience conducting focused analysis of internal and external complaint data
• 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 the medical device industry preferred

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
• Pension Plan
• Parental Leave and Adoption Services
• Health and Wellness Programs and Events

Laborie providesequal 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, sexualorientation,or any characteristic protected underapplicable law. Laborie is committed to providing access and reasonable accommodation in our services, activities, education, and employment for individuals with disabilities.