Medical Writer II

Laborie; Westborough (MA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Paid time off

Health insurance

401k with company match

Parental leave

Job summary

Laborie seeks a Medical Writer II to develop clinical, scientific, and regulatory documents for internal support, global regulatory agencies, and scientific conferences. You will collaborate with internal and external partners to support medical writing across Clinical and Regulatory needs, including CERs, CSRs, PMS data, and labeling materials.

Minimum qualifications include a BS in a scientific field or writing, 5+ years of medical/technical writing, and knowledge of MEDDEV 2.7/1 Rev 4, MDR

Qualifications

• Bachelor's degree in a scientific field or writing/composition and 5+ years' experience in medical or technical writing.
• Experience with Clinical Evaluation Reports (CERs) and MDR submissions.
• Knowledge of medical device regulations (ISO, MEDDEV, MDR, IVDR, FDA CFR).
• Ability to manage timelines and priorities with strong attention to detail.
• Proficient in MS Office and able to work independently and in a team.
• Excellent English verbal and written communication skills.

Responsibilities

• Performs literature searches and maintains literature reviews to support LABORIE's products.
• Critically appraises, analyzes, and summarizes data from experiments, trials, and publications for device claims and CERs/CSRs.
• Reviews post-market surveillance data for safety and effectiveness of LABORIE devices.
• Writes and edits scientific documents and presentations for internal teams and external partners.

Skills

MS Office

English writing/presentation

Project management

Attention to detail

Education

Bachelor's degree in a scientific field or writing/composition

Job description

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

About the Role

• 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.

Minimum Qualifications

• 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.
• Experience working in the medical device industry preferred.
• Project Management experience preferred.

Why Laborie

• 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 2025 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.