Medical Writer

6 days ago

Sanand Ahmedabad Gujarat, India Chetan Meditech Pvt. Ltd. - BIOTEK Full time

**Key Responsibilities**:
**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.

**Cross-functional Collaboration**:

- Interface closely with R&D, Clinical Affairs, Marketing, and Regulatory teams to access and identify the necessary preclinical, clinical and technical information.
- Develop clinical and marketing communication tools such as peer-reviewed manuscripts, white papers, one-pagers, slide decks, surgical techniques, and more.

**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.
- Critically appraise scientific literature and write clinical summaries to determine evidence gaps, assist in research and development of clinical strategies for clinical investigational protocols.

**Clinical Study Documentation**:

- Draft clinical trial protocols, ethics approval submissions, case report forms, informed consent documents, investigator brochures, clinical study reports, and support regulatory related submissions.
- Develop and manage clinical trial documentation: site master files, trial master files, Clinical trial logs, etc.

**Clinical Operations & Oversight**:

- Lead clinical budgeting and financial management, including preparation and negotiation of trial budgets, oversight of vendor contracts and clinical study agreements, 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.
- Initiate, monitor and close-out clinical studies on study sites in accordance with applicable national and international regulations, MDCGs, guidelines of ICH-GCP and NDCT-2019.

**Regulatory & Compliance Frameworks**:

- Ensure documentation aligns with latest MDR 2017/745 and relevant guidance (e.g., MEDDEV 2.7.1 Rev. 4, MDCGs, ISO 14155:2020, ISO 14971, ICH-GCP, 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 documents, ISO standards, and ICH-GCP guidelines.
- **Core Competencies**:

- Risk-benefit analysis
- Scientific writing (CER, BER, PMCF, PSUR, SSCP, etc.)
- Managing and supporting clinical studies/trials on medical devices
- Clinical trial documentation & project coordination
- Literature review & data appraisal
- Cross-functional communication and stakeholder engagement

**Required Knowledge of Guidelines and Standards**:

- EU MDR 2017/745
- MEDDEV 2.7.1 Rev. 04
- MEDDEV 2.12/2 Rev. 2
- MEDDEV 2.12/1
- MDCG 2020-5/6/7/8
- MDCG 2019-9 Rev.1
- ISO 14155:2020
- ICH-GCP
- New Drugs and Clinical Trials Rules, 2019
- ISO 10993-1
- ISO 14971
- ISO 24971

**Job Types**: Full-time, Permanent

Pay: ₹350,000.00 - ₹450,000.00 per year

**Benefits**:

- Commuter assistance
- Paid sick time
- Paid time off

Work Location: In person

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