Medical Writer / Sr. Medical Writer

Major Duties and Responsibilities

Responsibilities will include, but not be limited to:

• Author Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-Up (PMCF) documents
• Maintain periodic updates, perform gap analysis, and revise existing documents as necessary
• Interact with cross-functional teams to collect necessary information to be included in CERs and PMCF documents
• Stay abreast of advancements in relevant medical field and maintain knowledge of product area
• Collaborate with internal and external stakeholders to ensure comprehensive analysis of clinical evidence
• Support the clinical sections of global submissions and address inquiries from regulatory agencies pertaining to clinical documents
• May support the preparation of clinical study reports or other clinical study documents
• Ensure compliance with internal policies/procedures and external regulatory requirements
• May assist with development and maintenance of standard operating procedures and templates

Qualifications

Experience

• 3+ years (or 5+ years for Sr. Medical Writer) of medical writing experience in medical device industry
• Ability to write MDR-compliant CERs and PMCF documents
• Ability to conduct comprehensive literature searches, reviews, and analyses
• Advance knowledge of regulatory requirements associated with the preparation of clinical documents, e.g., EU MDR, MEDDEV 2.7/1 Rev 4, and relevant MDCG guidance
• Demonstrated understanding in clinical research
• Knowledge of medical device clinical trial strategy and study design is a plus

Education Requirements

• MS or PhD degree in scientific field, or MD/PharmD

Elixir Medical does not discriminate on the basis of race, sex, color, religion, marital status, national origin, gender, sexual orientation, gender identity, age, military veteran status, disability or any other reason prohibited by law.