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ClosedPosted 431 days ago

425649 Principal Medical Writer (Open)

ScaleneWorks INC

Where
Bengaluru Luxor North Tower

This posting closed on 2026-10-23.

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  6. 58.1%60 days
This job: posted 431 days ago

The posting

425649 Principal Medical Writer (Open)

## Job Summary The Principal Medical Writer will independently lead the preparation of complex clinical and post-market safety documents. This role is crucial in ensuring the quality and accuracy of documents that contribute to the organization’s goals in regulatory compliance and safety reporting.

## Responsibilities - Independently prepare complex clinical and post-market safety documents, including Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), and Risk Management Plans (RMPs). - Provide oversight to co-authors or a team of writers, ensuring accountability for the quality of their contributions. - Lead cross-functional teams in document preparation, including content strategy development, coordination of contributions, and organization of review schedules and project timelines. - Collaborate within a matrix team to deliver high-quality documents that accurately reflect safety, clinical, and statistical data in compliance with organizational standards and regulatory requirements. - Anticipate and resolve complex situations by leveraging scientific and operational knowledge in collaboration with stakeholders. - Assess trends in text and statistical data to effectively organize content and messages in safety documents. - Utilize authoring and reviewing tools, as well as automation/technology platforms, to expedite document preparation. - Mentor less experienced writers and develop training on medical writing topics. - Lead initiatives to improve medical writing processes and contribute to vendor oversight as needed.

## Qualifications - Bachelor's degree in Life Sciences, Medicine, Pharmacy, or a related field; advanced degree (e.g., Master's, PhD) preferred. - Proven experience in medical writing, particularly in clinical and post-market safety documentation. - Strong understanding of regulatory requirements and guidelines related to safety reporting. - Excellent written and verbal communication skills. - Ability to work collaboratively in a cross-functional team environment. - Strong analytical skills to assess data trends and patterns. - Proficiency in using document preparation tools and technology platforms.

## Preferred Skills - Experience with authoring and reviewing tools. - Familiarity with statistical analysis and interpretation. - Previous mentoring or training experience in medical writing.

## Experience - Minimum of 5-7 years of relevant experience in medical writing or a related field.

## Environment - Hybrid work mode, combining both in-office and remote work. - Based in Bengaluru Luxor North Tower.

## Salary - Estimated salary range: ₹6,500,000.

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