Medical Writer

1 month ago


Mysuru Karnataka, India Spectrum Talent Management Full time

**Job Title: Medical Writer**

**Key Responsibilities**:

- **Medical Writing**: Create, review, and edit high-quality, scientifically accurate documents including Clinical Evaluation Reports (CERs), Post-Market Surveillance (PMS) reports, and Periodic Safety Update Reports (PSURs).
- **Regulatory Compliance**: Ensure that all documents meet regulatory requirements and comply with relevant guidelines.
- **Data Analysis**: Gather and analyze clinical and safety data to support the development of documents and reports.
- **Collaboration**: Work closely with cross-functional teams including regulatory affairs, clinical research, and quality assurance to align documentation with project goals.
- **Research**: Conduct literature reviews and stay updated with current medical and scientific knowledge relevant to assigned projects.
- **Project Management**: Manage multiple writing projects and meet tight deadlines with high attention to detail and quality.
- **Quality Assurance**: Ensure the accuracy, consistency, and integrity of all medical documents.
- **Compliance with Regulations**: Maintain a strong understanding of global regulatory standards and guidance related to medical writing.

**Requirements**:

- **Experience**: Minimum [X] years of proven experience in medical writing, specifically with hands-on experience in CERs, PMS reports, and PSURs.
- **Domain Knowledge**: Must have a background in the medical domain (clinical or life sciences-related field).
- **Skills**:

- Excellent writing and editing skills with attention to detail.
- Strong organizational and time management skills.
- Proficiency in researching and synthesizing complex medical and scientific data.
- Ability to work independently and collaboratively in a fast-paced environment.
- **Education**: Bachelor’s or Master’s degree in life sciences, medical sciences, or a related field.

Pay: From ₹650,000.00 per year

Schedule:

- Day shift
- Monday to Friday

**Experience**:

- total work: 4 years (required)

Work Location: In person


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