Senior Medical Writer

Responsibilities

• Develop Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) for new medical devices

• Maintain and update CEPs, CERs, and PMCFP/PMCFRs per MEDDEV 2.7.1 Rev. 4 and EU MDR

• Ensure Good Documentation Practices and consistency of clinical documentation

• Review and analyze clinical and scientific data from studies, post-market surveillance and literature

• Identify clinical evidence gaps and contribute to strategic recommendations

• Collaborate with cross-functional teams on compliant documentation

• Manage timelines for assigned deliverables with project management

Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Medicine or related field

• Minimum 3 years of medical writing experience in pharma, biotech or CRO

• Strong medical device experience

• Experience writing CERs, CEPs and other clinical study documentation

• Proficiency in scientific and medical terminology

Benefits

• Competitive base salary and performance related incentives

• Medical, dental and vision coverage where applicable

• Retirement and pension plans

• Life assurance and disability coverage

• Learning and development opportunities

About the Company

ICON is a clinical research organisation delivering new medicines and medical devices. As the world's largest FSP organisation, it offers sponsor-dedicated roles.