Changing lives. Building Careers.
 

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

The Medical Communications-Medical Writing Specialist is an intermediate-level professional within the medical communications department who supports scientific and clinical initiatives and deliverables. The role applies established, regulatory knowledge, and best practices to deliver high-quality medical writing, editorial review, and lifecycle document management.
This position requires strong research, writing and editing skills.  The Specialist collaborates closely with cross-functional partners, manages documentation deliverables, and supports regulatory and clinical activities aligned with EU MDR, FDA guidance, and internal quality standards.

Supervision Received: Reports to the Medical Writing Manager and receives moderate instruction and guidance to achieve objectives.

Supervision Exercised: None.

Key Responsibilities

• Edit, review, and format medical writing deliverables to ensure scientific accuracy, clarity, consistency, and regulatory compliance.
• Support Clinical Evaluation Reports (CERs), PMCF plans, PMCF evaluation reports, clinical summaries, and related regulatory documentation in alignment with EU MDR requirements.
• Maintain project trackers, timelines, deliverables, dashboards, and workflow tools to support department operations.
• Coordinate with cross-functional stakeholders to support post-market clinical follow-up activities and document updates.
• Manage reference libraries and literature management tools; coordinate issue resolution with IT and software vendors as needed.
• Ensure secure storage, retrieval, version control, and inspection readiness of medical communications documentation.
• Support vendor coordination to ensure timely, high-quality document deliverables.
• Prepare meeting agendas, track action items, and distribute meeting notes and resources.
• Ensure departmental procedures and documentation comply with applicable clinical, regulatory, and quality requirements.
• Update and track global standard operating procedures and support Change Review Board preparation activities.
• Monitor project risks and stakeholder needs to ensure alignment with departmental objectives.

Required Skills & Minimum Qualifications

Education:

• Master’s degree or PhD in scientific discipline is preferred.
• Bachelor’s degree in scientific or healthcare discipline may be considered with six years of experience.  

Experience:

• Minimum 2 of years of writing experience in the medical device or pharmaceutical industry.
• Experience with systematic literature reviews, writing literature protocols and literature reports.
• Ability to produce clinical evaluation plans/reports with minimal oversight.
• Strong technical writing skills.
• Bibliographic research and editorial skills.
• Ability to interpret and disseminate relevant product information.
• Proficiency in MS Office applications.
• Proficiency in EndNote or Reference Manager.
• Basic understanding of regulatory compliance for medical devices.
• Maintains general knowledge of industry, regulatory, marketing, linguistic, and publication standards and applies this knowledge to the completion of all projects.
• Strong organizational skills, attention to detail and proofreading skills.

Skills:

• Working knowledge of EU MDR clinical evaluation and post-market clinical follow-up requirements.
• Strong medical writing, editing, and document management capabilities.
• High attention to detail and document quality.
• Proficiency with Microsoft Word, Excel, PowerPoint, Adobe Acrobat, and document management systems.
• Strong communication and collaboration skills.

Tools and Equipment Used

General office equipment, Microsoft Office Suite (Word, Excel, PowerPoint), Adobe Acrobat, and document and reference management systems.

Physical Requirements

Ability to sit and work at a computer for extended periods, with visual acuity sufficient for detailed document review.

Adverse Working Conditions

This position does not involve adverse or hazardous working conditions.

Salary Pay Range:

$62,000.00 - $85,000.00 USD Salary

Our salary ranges are determined by role, level, and location. Individual pay is determined by several fact