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Position : Senior Medical Writer – RWE

Location : Bangalore

Job Type : Full-time

Department : Medical Writing – MCAPL

Job Description

The Senior Medical Writer – RWE will be responsible for authoring, reviewing, and managing high-quality scientific and regulatory documents. The role requires strong scientific understanding, writing expertise, and the ability to lead real-world evidence (RWE) and epidemiological studies that support clinical and regulatory objectives.

Key Responsibilities

• Author, edit, and review a wide range of documents including clinical protocols, study reports, investigator brochures (IBs), regulatory submissions, manuscripts, abstracts, and presentation materials.
• Design and lead real-world data and epidemiological studies (protocols, data collection, analysis, and interpretation) to assess disease trends, health outcomes, and risk factors.
• Support regulatory submissions and deliver study reports, publications, and presentations.
• Translate complex scientific and clinical findings into clear, audience-specific content for regulators, sponsors, patients, and healthcare professionals.
• Conduct comprehensive literature reviews to support evidence-based writing and ensure scientific accuracy.
• Collaborate with cross-functional teams (clinical, regulatory, medical, marketing, and technical) to maintain consistency and integrity in scientific messaging.
• Participate in cross-departmental meetings to align on expectations, gather insights, and support project timelines.
• Incorporate feedback from internal reviewers, external stakeholders, and quality review processes to refine deliverables.
• Manage document version control and workflow tracking in accordance with project management systems.
• Stay updated on therapeutic area advancements, regulatory changes, and best practices in medical writing.
• Provide technical mentorship, manage project timelines and budgets, and ensure compliance with evolving public health and regulatory standards.
• Clinical Data Management : Lead eCRF design, data collection, entry, validation, and query management; perform database testing (including UAT); ensure timely delivery of clean, reliable datasets through interim reviews and database lock.
• Quality and Compliance : Prepare DMPs / DVPs, implement edit checks and reconciliation procedures, coordinate with vendors and cross-functional teams, and maintain compliance with GCP, ICH, and 21 CFR Part 11 while driving process improvements.

Qualifications

Preferred Attributes