Scientific Writer

3 days ago

Ahmedabad, Gujarat, India Veeda CR Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Role & responsibilities

1. Works closely with cross-functional project teams to independently author scientifically accurate, comprehensive and compliant documents, including but not limited to clinical study reports, clinical study protocols, manuscripts, informed consent forms, patients' narratives, abstracts, posters, oral presentations, etc.

2. Manages the collection, consolidation and integration of comments/feedback from internal and external reviewers to efficiently finalize assigned writing projects

3. Performs thorough quality control checks, including copyediting, proofreading, and cross-verification of data within clinical documents and against source TFLs to ensure accuracy, consistency, and compliance with regulatory standards.

4. Ensure that the assigned deliverables strictly adhere to regulatory guidelines (e.g., ICH-GCP, EMA/FDA requirements), publication guidelines (ICMJE, GPP, journal/congress-specific requirements), client specifications, and Veeda's quality standards for content, format, and structure.

5. Streamline the review process by identifying and mitigating potential conflicts early, enabling the timely completion of high-quality deliverables.

6. Provide supervision and technical advice to other medical writers in the team and new writers joining the team, as required.

7. Apply broad therapeutic knowledge to adapt writing style and content for different disease areas and target audiences

8. Conduct literature reviews on assigned therapeutic areas and provide scientific support across departments throughout the clinical study lifecycle, ensuring adherence to timelines and project requirements.

9. Quickly assimilate new therapeutic area information to support emerging project needs

10. Maintain awareness of evolving guidelines and standards across relevant therapeutic fields

11. Provide support to Medical Writing department activities as needed

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