Protocol Writing- Bangalore-us Based Mnc

1 month ago

Bengaluru, India Elixir Consulting Full time

Location
- Bangalore- Industry
- Pharmaceutical & Healthcare- Contract Type
- Permanent- Salary
- Published
- 20 days ago
- Contact
- Somya Mishra- Reference
- 29-13-10118- Academic title
- Bachelor of PharmacyJob description
- Effectively collect and evaluate data, information, and input from multiple sources, functions, and regions to create a cohesive content strategy for writing projects.
- Regulatory writing experience - Clinical study reports, IBs, protocols, protocol amendments, CTD modules, etc.
- Plan (including organizing/preparing outlines), write (including first-draft authoring), edit, review, coordinate, and complete the regulatory documents supporting clinical development/product registration.
- Conduct effective document initiation meeting to ensure authoring team alignment and understanding.
- Build scientific-based rationale that support the purpose of more complex and/or strategic documents.
- Ensure data are presented in a clear, complete, accurate, and concise manner.
- Ensure that key data, statements and conclusions are consistent across related documents, and that statements and conclusions are integrated, accurate, balanced and supported by appropriate data.
- Coordinate expert/scientific reviews, collate reviewer’s comments, adjust content of document as required based on internal/external input, and prepare final version.
- Ensure and coordinate quality checks for accuracy.
- Exhibit flexibility in moving across development and preparation of multiple document types.
- Influence or negotiate change of timelines and content with other team members.
- Work with internal and external experts to develop and prepare presentations.
- As needed, may build and manage relationships with vendors/alliance partners.

**Requirements**:
Having 2 to 5 Years of experience into Protocol Writing

**Benefits**:

- Excellent Compensation
- Global Exposure
- Hybrid Mode

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