Top 7 Medical writer Jobs in Berlin Ma

Medical Writer II
Laborie Medical Technologies Corp —Westborough, MA
- $115,000 - $120,000 a year
- Full-time
- 5 years
- English
- Microsoft Office
- Dental insurance
- Paid time off
Quick Apply
Director, Medical Writing
Alkermes, Inc. —Waltham, MA
- Full-time
- Management
- Psychiatry
- Doctor of Philosophy
Global Head, Medical Writing
Merck KGaA —Billerica, MA
- $234,800 - $352,200 a year
- Hybrid work
- 11+ years
- Master's degree
- Doctor of Philosophy
- Health insurance
- Paid time off
Associate Director / Director - Medical Writing, Oncology
Treeline Biosciences —Watertown, MA
- $164,450 - $224,787 a year
- Remote
- 8 years
- Bachelor's degree
- Doctor of Philosophy
Quick Apply
3d
Associate Director, Medical Writing
Alkermes, Inc. —Waltham, MA
- Full-time
- Doctoral degree
- Psychiatry
- Neurology
Senior Regulatory Medical Writer, Client-embedded, FSP
Thermo Fisher Scientific —Framingham, MA
- $105,000 - $125,000 a year
- Full-time
- Microsoft Outlook
- Bachelor's degree
- Team management
- Commuter assistance
- Paid parental leave

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Medical Writer II

Laborie Medical Technologies Corp -
Westborough, MA

Quick Apply

Job Details

Full-time
$115,000 - $120,000 a year

Benefits

Dental insurance
Paid time off
Adoption assistance
Pension plan
Parental leave
Vision insurance

Qualifications

Medical writing
English
Microsoft Office
Bachelor's degree
Compliance documentation
Clinical data report preparation
Biomedical regulatory compliance
Clinical research reports
Clinical data analysis
Scientific reports

Full 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 insupport 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
Project Management experience 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
Medical, Dental, Vision
Pension Plan
Parental Leave and Adoption Services
Health and Wellness Programs and Events

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.

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Refine Your Search

medical writer jobs in berlin ma

Medical Writer II

Director, Medical Writing

Global Head, Medical Writing

Associate Director / Director - Medical Writing, Oncology

Associate Director, Medical Writing

Senior Regulatory Medical Writer, Client-embedded, FSP

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