Medical Writer

XPER Research; Indiana (PA); On-site; USD 70,000 - 110,000; Full time

Job summary

XPER Research is seeking a scientific writer to develop, write and edit regulatory documents and technical documentation for medical devices and IVDs, including Clinical Evaluations Plans and Reports and Performance Evaluation Plans and Reports.

You will perform MDR/IVDR-compliant literature reviews, prepare study protocols and consent forms, and draft scientific publications while ensuring compliance with regulations, standards and client requirements.

Qualifications

• Master's or advanced degree in a scientific, medical, or life sciences field.
• Previous experience in a medical writing role or clinical operations role in medical devices or IVDs preferred.
• Proficiency in English writing and communication.

Responsibilities

• Develop, write and edit regulatory documents and technical documentation for medical devices and IVDs (e.g., Clinical Evaluations Plans/Reports, Performance Evaluation Plans/Reports).
• Perform MDR/IVDR-compliant systematic literature reviews.
• Develop, write and edit documentation for clinical studies (protocols, informed consent forms, study reports).
• Write scientific publications and communication documents related to medical devices and IVDs.
• Ensure all documents comply with regulations, standards, client requirements and internal procedures.
• Collaborate with cross-functional teams and clients to gather input and align regulatory strategy.
• Deliver within agreed timelines and budget.
• Stay updated on regulatory changes and best practices.

Skills

Scientific Literacy

Regulatory guidelines knowledge

Data interpretation

Time management & prioritization

Attention to detail

Adaptability

Self-motivated & independent worker

Education

Master's or advanced degree in scientific/medical field

Job description

Do You Recognize Yourself In Below Skills & Competences

• Scientific Literacy: strong foundation in life sciences, biomedical sciences, or medicine; able to understand and accurately interpret complex scientific and clinical data.
• Knowledge of regulatory guidelines: familiarity with applicable regulatory guidelines (e.g., EU MDR, IVDR, FDA, MDCG guidance documents) and Good Clinical Practices (GCP).
• Data Interpretation: Ability to interpret, synthesize and present clinical and scientific data clearly and concisely, without unnecessary complexity.
• Time Management & Prioritization: Capable of handling multiple projects and deadlines efficiently, with strong organizational skills.
• Attention to Detail: Strong focus on accuracy, consistency, grammar, and data integrity in all written materials while maintaining oversight of the bigger picture.
• Adaptability: Comfortable working in dynamic environments, managing shifting priorities, evolving project scopes and cross-functional collaborations.
• Self-Motivated & Independent Worker: Proactive and reliable, with the ability to work independently and contribute meaningfully to team efforts.

In This Role, You Will Have The Opportunity To

• Develop, write and edit regulatory documents and technical documentation for medical devices and IVDs, such as Clinical Evaluations Plans and Reports, Performance Evaluation Plans and Reports.
• Perform MDR or IVDR-compliant systematic literature reviews.
• Develop, write and edit documentation for clinical studies for medical devices and IVDs, such as protocols, informed consent forms, and study reports.
• Write scientific publications and communication documents related to medical devices and IVDs.
• Ensure all documents are compliant with relevant regulations, industry standards, client-specific requirements and internal procedures.
• Collaborate closely with cross-functional teams and clients to gather and interpret input for the documents and ensure alignment on regulatory strategy.
• Deliver within the agreed timelines and budget.
• Stay updated on regulatory changes and medical writing best practices.

The Essential Requirements For The Job Include

• Master or advanced degree in a scientific, medical, or life sciences field.
• Previous experience in a medical writing role or clinical operations role in the medical device or IVD field and/or willingness to follow medical writing training.
• Proficiency in Microsoft Office Suite and reference management software.
• Excellent written and verbal communication skills in English.