Medical Writer

About the role

The Medical Affairs Medical Writer will combine their knowledge of science with their understanding of research and writing to present information effectively and clearly.

The Medical Writer will focus on scientific medical writing to prepare documents for submission to regulatory bodies.

The Medical writer will interface with other functions as necessary to ensure accurate and timely completion and review of documents for clinical regulatory submissions.

The Medical Writer will be expected to conduct comprehensive literature searches regarding subject medical devices.

Responsibilities

• Combine knowledge of science with understanding of research and writing to present information effectively and clearly.
• Focus on scientific medical writing to prepare documents for submission to regulatory bodies.
• Interface with other functions as necessary to ensure accurate and timely completion and review of documents for clinical regulatory submissions.
• Conduct comprehensive literature searches regarding subject medical devices.

Requirements

• Minimum of a Bachelor’s Degree required. Advanced degree preferred.
• Medical background required
• Minimum of 2-3 years writing experience.
• Ability to write with scientific accuracy and to compile, write, and edit documents for submission to regulatory agencies.
• (Writing samples required)
• Experience in Medical Device industry strongly preferred
• Certification through the American Medical Writing Association (AMWA) or other relevant association is preferred.
• Ability to conduct comprehensive literature searches and interpret / summarize / synthesize relevant literature
• Understanding of MEDDEV 2.7/1 rev4 guidelines and the MDR regulations related to clinical evaluation reports preferred.
• Ability to ensure that all deliverables are in accordance with applicable regulations, standards, and guidelines
• Excellent written and verbal communication skills.
• Superior attention to detail.
• Proficiency in MS Office with expertise in Microsoft Word, PowerPoint and Excel with a special focus on word processing, tables, spreadsheets, presentations, graphics and templates.
• Proficiency with a PC
• Excellent time management skills, and able to meet deadlines
• Working knowledge of statistical concepts and techniques.
• Experience in working with collaborative, cross-functional teams.
• Ability to function well both individually and as part of a team.

Qualifications

• Minimum of a Bachelor’s Degree required. Advanced degree preferred.
• Medical background required
• Minimum of 2-3 years writing experience.
• Experience in Medical Device industry strongly preferred
• Certification through the American Medical Writing Association (AMWA) or other relevant association is preferred.
• Ability to conduct comprehensive literature searches and interpret / summarize / synthesize relevant literature
• Understanding of MEDDEV 2.7/1 rev4 guidelines and the MDR regulations related to clinical evaluation reports preferred.
• Proficiency in MS Office with expertise in Microsoft Word, PowerPoint and Excel with a special focus on word processing, tables, spreadsheets, presentations, graphics and templates.
• Proficiency with a PC
• Excellent time management skills, and able to meet deadlines
• Working knowledge of statistical concepts and techniques.
• Experience in working with collaborative, cross-functional teams.
• Ability to function well both individually and as part of a team.

Skills

• Excellent written and verbal communication skills.
• Superior attention to detail.
• Proficiency in MS Office with expertise in Microsoft Word, PowerPoint and Excel with a special focus on word processing, tables, spreadsheets, presentations, graphics and templates.
• Proficiency with a PC
• Excellent time management skills, and able to meet deadlines
• Working knowledge of statistical concepts and techniques.
• Experience in working with collaborative, cross-functional teams.
• Ability to function well both individually and as part of a team.

Benefits

• 40 hour / week with occasional pre-approved overtime
• Position requires work to be accomplished in the office

Pay

• Not specified

Schedule

• Not specified