Medical Writer

2 weeks ago

Sanand Ahmedabad Gujarat, India KK HR services Full time

**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.).

**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

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

**Benefits**:

- Provident Fund

**Experience**:

- Medical Writer: 7 years (required)

Work Location: In person

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