Medical Writer - on Site

Key Responsibilities:

1. Clinical Evidence Development:

· Author and maintain high-quality clinical documents including CERs, CEPs, PMCFPs, PMCFRs, PMSP, PSURs, and SSCPs in line with EU MDR and other international standards.

· Conduct thorough risk–benefit analyses and integrate data from preclinical, clinical, and post-market sources.

2. Cross-functional Collaboration:

· Interface closely with R&D, Clinical Affairs, Marketing, and Regulatory teams to translate technical data into meaningful documentation.

· Develop clinical and marketing communication tools such as peer-reviewed manuscripts, white papers, one-pagers, slide decks, surgical techniques, and more.

3. Scientific Literature Research & Analysis:

· Design robust and reproducible literature search strategies.

· Perform systematic literature reviews and create comprehensive State of the Art summaries across diverse indications and implant technologies.

4. Clinical Study Documentation:

· Draft clinical trial protocols, case report forms, informed consent documents, investigator brochures, and support related regulatory submissions.

· Develop and manage clinical trial documentation: site master files, trial master files, Clinical trial logs, etc.

5. Clinical Operations & Oversight:

· Lead clinical budgeting and financial management, including preparation and negotiation of trial budgets, oversight of vendor contracts and clinical study agreements, and management of investigator and site payments.

· Oversee aspects of clinical operations, including monitoring visits, generation of reports, and coordination with third-party CROs and sites.

· Draft clinical study agreements, insurance documents, and ensure operational compliance across trial activities.

6. Regulatory & Compliance Frameworks:

· Ensure documentation aligns with latest MDR 2017/745 and relevant guidance (e.g., MEDDEV 2.7.1 Rev. 4, MDCG guidelines, ISO 14155:2020, ISO 14971, etc.).

· Interpret and apply risk management standards and post-market surveillance frameworks, contributing to proactive safety strategies.

Essential Requirements:

· Domain Expertise: Proven experience in authoring regulatory and clinical documents for non-active implantable medical devices.

· Regulatory Acumen: Solid understanding of relevant global regulatory frameworks, especially EU MDR, MEDDEV, MDCG guidance, and ISO/ICH standards.

· Core Competencies:

¾ Risk–benefit analysis

¾ Scientific writing (CER, BER, PMCF, PSUR, SSCP, etc.)

¾ Clinical trial documentation & project coordination

¾ Literature review & data appraisal

¾ Cross-functional communication and stakeholder engagement

Required Knowledge of Guidelines and Standards:

¾ EU MDR 2017/745

¾ MEDDEV 2.7.1 Rev. 04

¾ MEDDEV 2.12/2 Rev. 2

¾ MEDDEV 2.12/1

¾ MDCG 2020-5/6/7/8

¾ MDCG 2019-9 Rev.1

¾ ISO 14155:2020

¾ ICH-GCP

¾ New Drugs and Clinical Trials Rules, 2019

¾ ISO 10993-1

¾ ISO 14971

¾ ISO 24971

Job Type: Full-time

Pay: ₹1,200,000.00 - ₹1,500,000.75 per month

Benefits:

• Provident Fund

Experience:

• Medical Writer: 7 years (Required)

Work Location: In person