Medical Writer – Remote Role at Kelly Science

Are you passionate about scientific writing and regulatory documentation?
Kelly Science, Engineering, Technology & Telecom is hiring a Medical Writer to support its global medical device documentation team. This is a remote, full-time contract opportunity where you will craft high-quality regulatory and clinical documents such as Clinical Evaluation Reports (CERs), Summary of Safety and Clinical Performance Reports (SSCPs), and Systematic Literature Reviews (LRRs).

This role offers an exciting opportunity for experienced medical writers in India to work on international projects and contribute to evidence-based medical device documentation.

Key Responsibilities

• Prepare, update, and maintain CERs, SSCPs, SOAs, and LRRs in compliance with EU MDR and MEDDEV 2.7.1 Rev 4 regulations.
• Conduct and participate in systematic literature reviews, including database search, screening, extraction, and synthesis.
• Perform risk-benefit analyses and summarize clinical and regulatory data for medical devices.
• Compare device performance against state-of-the-art standards and investigate unexpected outcomes.
• Collaborate with Regulatory Affairs, R&D, Medical Directors, and Quality Teams.
• Use tools such as Microsoft Office, EndNote, Distiller, Wrike, and AI-based systems for document creation.
• Adhere to company SOPs and global health and safety standards.

Qualifications and Experience

• Education: Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related discipline; advanced degree preferred.
• Experience: Minimum 3 years in medical writing (preferably in the medical device industry).
• Knowledge of MDCG/MDR guidelines and CER documentation standards is a strong advantage.
• Proven ability to perform literature searches, summarize clinical data, and analyze device safety and performance.
• Strong communication, project management, and teamwork skills.
• Experience with post-market surveillance or adverse event reporting is desirable.

Why Join Kelly Science

• Work remotely with a global leader in scientific talent solutions.
• Collaborate with experts in regulatory, clinical, and device documentation.
• Competitive compensation and opportunities for contract extension.
• Gain international exposure in medical device regulatory writing.

How to Apply

Application Link