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.