Medical Writer

Job Description

Role Summary:

The Medical Writer is responsible for authoring, reviewing, and maintaining clinical and regulatory documents for medical devices, supporting clinical evidence generation and regulatory compliance throughout the product lifecycle.

Key Result Areas:

1. Medical Device Medical Writing

• Medical Writing - Authoring, updating, and reviewing medical device-focused documents in the Regulatory and Clinical space:

• Clinical Evaluation Plans (CEP) / Reports (CER)
• Post-Market Clinical Follow-Up (PMCF) Plans / Reports
• Clinical Investigation Plan (CIP) / Protocol
• Clinical Study Reports (CSRs)
• Summaries of Safety and Clinical Performance (SSCP)
• Informed Consent Documents (ICD)
• Investigator's Brochure (IB)
• Periodic Safety Update Reports (PSUR)
• Publications and White Papers
• Health Hazard Analysis (HHA) / Evaluation (HHE) or Public Health Threat Analysis (PHTA)
• Other pertinent documents

Literature Science: Literature search strategy, conduct, summary and reports

• Preparation of literature search protocols and search strategies
• Conducting systematic literature searches to gather clinical data, evaluate evidence, and extract data for inclusion in reports
• Preparation of literature summary reports and literature-based documents such as State-of-the-Art (SotA)

2. Organizational Responsibilities

• Regulatory Compliance: Ensuring all documents adhere to India MDR, EU MDR, ISO 13485, other regulatory requirements, and company SOPs.

• Collaboration: Working with Regulatory Affairs, Quality, and R&D teams to align clinical data with safety and performance requirements.

Required Qualifications & Skills:

• Education: Medical Graduation - only MBBS or BHMS candidates may apply. Exceptionally good Pharm D candidates with exposure and understanding of Medical Devices may be considered.

• Experience: 0-3 years of experience in Medical Device Medical Writing or Clinical Affairs.

• Knowledge: Deep understanding of EU MDR requirements, literature search methodologies, and clinical data interpretation.

• Skills: Exceptional writing/editing skills, proficiency in English, understanding of French/Portuguese is an added advantage, attention to detail, proficiency in MS Office (Word/Excel), and strong analytical thinking