Cer Technical Medical Writer (Amravati)

Kelly Science, Engineering, Technology & Telecom; Amravati; On-site; INR 600,000 - 900,000; Full time

Job summary

Kelly Science, Engineering, Technology & Telecom in India seeks a Medical Writer to join our Scientific Operations team on a 12-month fixed-term contract. You will create, update, and manage regulatory and clinical documents for orthopaedic device projects.

The role requires writing CERs, SSCPs, SOAs, and LRRs, plus data synthesis from systematic literature reviews, with collaboration across Medical Directors, Regulatory Affairs, and Design Quality Engineers.

Qualifications

• BA, BS or BSN required; advanced degree preferred.
• Minimum of 3 years experience in medical writing or related roles.
• Experience in the medical device industry and knowledge of CER regulatory requirements, evidence generation, and literature reviews preferred.
• Familiarity with clinical research, quality/regulatory compliance, and adverse event reporting is a plus.

Responsibilities

• Write and update CERs, SSCPs, SOAs, and LRRs in compliance with regulatory requirements.
• Participate in core steps of systematic literature reviews (search, screening, data extraction, analysis, synthesis).
• Summarize clinical, non-clinical, and regulatory data to perform risk/benefit analyses on medical devices.
• Collaborate with cross-functional teams including Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs.

Skills

Oral communication

Presentation

Project management

Prioritization

Education

BA/BS/BSN

Advanced degree preferred

Tools

Microsoft Office

EndNote

Distiller

Wrike

In-house AI tools

Job description

Job Title: Medical Writer Fixed Term Contract (12 months, Full Time) - Orthopaedic DevicesLocations: IndiaDepartment: Scientific OperationsAbout the Role: We are seeking a Medical Writer to join a dynamic scientific operations team supporting medical device projects. This is a full-time, site-based role on a 12-month fixed-term contract with the potential for extension. The Medical Writer will create, update, and manage a range of regulatory and clinical documents including Clinical Evaluation Reports (CERs), Summary of Safety and Clinical Performance Reports (SSCPs), State of the Art Reviews (SOAs), and Systematic Literature Reviews (LRRs) within their assigned therapeutic area.

Key Responsibilities:

• Write and update CERs, SSCPs, SOAs, and LRRs in compliance with applicable regulatory requirements and guidelines (MUST HAVE)
• Participate in all core steps of systematic literature reviews, including search, screening, data extraction, analysis, and synthesis
• Summarize clinical, non-clinical, and regulatory data to perform risk/benefit analyses on medical devices
• Compare device safety and performance against the state of the art and investigate unexpected outcomes
• Utilize various software systems, including Microsoft Office, End Note, Distiller, Wrike, and in-house AI tools, to create required documents
• Follow all company procedures, regulatory guidelines, and health, safety, and environmental practices
• Collaborate with cross-functional teams including Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs
• Communicate business-related issues or opportunities to management effectively

Education & Experience Requirements:

• BA, BS, or BSN required; advanced degree preferred
• Minimum of 3 years experience in medical writing or related roles
• Experience in the medical device industry and knowledge of CER regulatory requirements, evidence generation, and literature reviews preferred
• Familiarity with clinical research, quality/regulatory compliance, and adverse event reporting is a plus
• Strong oral communication, presentation, project management, and prioritization skills

Additional Qualifications/Desirable:

• Background in life sciences (Dentistry, Optometry, Veterinary Science, etc.) is welcomed
• Experience with CER creation, MEDDEV 2.7.1 rev 4, MDCG/MDR regulations considered a strong advantage
• Proven ability to perform literature searches, summarize clinical conditions, and assess risks and benefits for medical devices
• Experience reviewing supporting device documentation and analyzing device performance data

This is an exciting prospect for a detail-oriented professional to contribute to regulatory and scientific documentation within the medical device sector while working in a collaborative, cross-functional environment. .