Purpose of the role:

We are seeking an experienced Medical Writer to join our Clinical Affairs team. The successful candidate will be responsible for developing high-quality clinical, scientific, regulatory, and technical documents supporting Occlutech's global medical device portfolio.

The role requires strong scientific writing capabilities, medical device industry expertise, and the ability to work collaboratively with Clinical Affairs, Regulatory Affairs, Medical Affairs, Quality, and R&D; teams. Experience utilizing AI-based tools to improve content development, literature review, document management, and productivity will be highly valued..

Roles & Responsibilities:

1) Medical & Clinical Writing

- Prepare, review, and edit clinical and scientific documents for global regulatory and clinical purposes.
- Develop Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), PMCF Plans and Reports, Clinical Investigation Reports (CIRs), and Summary of Safety and Clinical Performance (SSCP) documents.
- Support preparation of regulatory submission documents and technical documentation.
- Draft scientific manuscripts, abstracts, posters, conference presentations, and white papers.
- Ensure all documents are scientifically accurate, consistent, and compliant with applicable regulations.

2) Literature Review & Evidence Generation

- Conduct systematic literature searches and literature reviews.
- Analyze published clinical evidence and summarize findings.
- Support clinical evidence generation activities in accordance with EU MDR requirements.
- Evaluate scientific data and support risk-benefit assessments.

3) AI-Enabled Documentation & Innovation





- Utilize AI tools and digital technologies to enhance document development, content review, scientific research, and productivity.
- Support implementation of best practices for AI-assisted medical writing workflows.
- Evaluate emerging technologies that can improve content quality and efficiency.
- Collaborate with stakeholders to optimize documentation processes using digital solutions.

4) Cross-Functional Collaboration

- Work closely with Clinical Affairs, Regulatory Affairs, Medical Affairs, Quality, and Product Development teams.
- Support global regulatory submissions and clinical documentation requirements.
- Coordinate with subject matter experts to obtain technical and scientific inputs.
- Ensure timely completion of assigned writing projects.

5) Quality & Compliance

- Ensure compliance with EU MDR, MEDDEV guidance documents, ISO 14155, GCP, and internal quality procedures.
- Maintain document traceability and version control.
- Support audit and inspection readiness activities.

Skills & Qualifications:

Mandatory

- Strong scientific and medical writing skills.
- Experience preparing clinical and regulatory documentation.
- Proficiency in literature review and evidence synthesis.
- Experience using AI tools to support medical writing and content development.
- Excellent English language writing and editing skills.
- Robust understanding of document quality and compliance requirements.

Preferred

- Knowledge of EU MDR and MEDDEV requirements.
- Familiarity with Clinical Evaluation Reports (CER), PMCF documentation, and Clinical Investigation Reports.
- Experience with reference management software and document management systems.
- Knowledge of statistics and clinical research methodologies.

📌 Medical Writer - EU Region (Clinical Affairs) (Mumbai)
🏢 Alkem MedTech
📍 Mumbai