Medical Writer

7 days ago

Goregaon Mumbai Maharashtra, India Pink Sky HR Services Full time

**Job Summary**:
**Key Responsibilities**:

- **Content Development**:

- Create, write, and edit clinical study reports, patient narratives, manuscripts, regulatory documents (such as Clinical Study Protocols, Investigator’s Brochures, and Clinical Study Reports), and other scientific documents.
- **Regulatory Submissions**:
Assist in the preparation of documents for regulatory submissions to agencies such as the FDA, EMA, and other health authorities, ensuring compliance with regulatory guidelines and timelines.
- **Data Interpretation**:
Analyze, interpret, and present complex scientific and clinical data in a clear, accurate, and concise manner for various audiences.Work closely with cross-functional teams, including clinical research, biostatistics, regulatory affairs, and medical affairs, to obtain relevant data and insights needed for writing.Conduct literature reviews and stay up-to-date on medical and scientific developments in the relevant therapeutic areas.Ensure all written materials meet industry standards and are compliant with regulatory requirements and company guidelines (e.g., Good Clinical Practice, Good Publication Practice, ICH guidelines).Review and edit documents for accuracy, consistency, grammar, and style, adhering to internal standards and external submission requirements.**Requirements**:

- **Collaborative Writing**:

- **Literature Review**:

- **Compliance**:

- **Editing and Quality Control**:

- **Education**:

- Bachelor’s degree in life sciences, pharmacy, medicine, or related field (Master’s or PhD preferred).
- **Experience**:
2-5 years of experience in medical writing within the pharmaceutical, biotechnology, or medical device industry.
- **Skills**:

- Strong understanding of medical/scientific terminology and statistical concepts.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with relevant medical writing software.
- Ability to work with tight deadlines and manage multiple projects simultaneously.
- Excellent communication skills and attention to detail.
- Familiarity with regulatory submission processes and industry standards (FDA, EMA guidelines, ICH GCP).
- **Certifications (Optional)**:
Certification from AMWA (American Medical Writers Association) or EMWA (European Medical Writers Association) is a plus.**Preferred Qualifications**:

- Experience writing in specific therapeutic areas (e.g., oncology, neurology, cardiology, etc.).
- Prior experience working with CROs or in a medical communications agency.
- Familiarity with publication processes and best practices for manuscript preparation

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

Pay: ₹25,000.00 - ₹65,000.00 per month

Schedule:

- Night shift
- Rotational shift
- UK shift
- US shift

**Experience**:

- total work: 1 year (preferred)

Work Location: In person

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