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ClosedPosted 367 days ago

428769 - Principal Medical Writer

ScaleneWorks INC

Where
Bangalore

This posting closed on 2026-10-23.

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  6. 58.1%60 days
This job: posted 367 days ago

The posting

Clinical Regulatory Writer

## Company Overview Company details are currently unavailable.

## Job Summary The Clinical Regulatory Writer plays a crucial role in the pharmaceutical industry, responsible for the creation of high-quality clinical regulatory documents. This position requires expertise in analyzing and documenting clinical data while ensuring compliance with industry standards to support the development and approval of pharmaceuticals.

## Responsibilities - Prepare and manage clinical regulatory documents required for submissions to health authorities. - Collaborate with cross-functional teams to interpret and document clinical data effectively. - Demonstrate leadership in project management and provide guidance in multicultural settings. - Ensure compliance with International Conference on Harmonisation (ICH) and Good Clinical Practice (GCP) guidelines. - Utilize strong computer skills for document formatting and data analysis. - Communicate complex information clearly in both verbal and written English.

## Qualifications - Education: PhD or relevant working experience within the life sciences space. - Experience: Clinical regulatory writing in the pharmaceutical industry. - Skills: - Leadership abilities. - Experience working in multicultural environments. - Proficient in interpreting and documenting clinical data. - Knowledge of ICH/GCP standards. - Strong computer skills and general computer literacy. - Excellent English language skills (verbal and written).

## Preferred Skills - Additional experience in remote teamwork and collaboration with diverse groups is advantageous. Familiarity with regulatory submission processes would be a plus.

## Experience - Minimum of relevant experience in clinical regulatory writing, particularly within the pharmaceutical sector.

## Environment Details on the typical work setting, location, or physical conditions are not provided.

## Salary Salary information is currently unavailable.

## Growth Opportunities Opportunities for career advancement within the pharmaceutical industry exist, although specific pathways are not detailed.

## Benefits Information regarding benefits offered for this position is not specified.

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