Position: Senior Medical Writer-RWE

Location: Bangalore

Job Type: Full time employment

Department: Medical Writing-MCAPL

Job description and responsibilities:
Author, edit, and review a wide spectrum 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.
Convert detailed scientific and clinical findings into content tailored for diverse stakeholders such as regulators, sponsors, patients, and healthcare specialists.
Conduct comprehensive literature research to support evidence-based writing and maintain the integrity of scientific messaging.
Work collaboratively with clinical, regulatory, medical, marketing,



and technical teams to maintain scientific accuracy and message consistency across deliverables.
Participate in cross-departmental meetings to gather insights, align on expectations, and support project timelines.
Incorporate feedback from internal reviewers, external stakeholders, and quality review processes to refine documents.
Oversee document version control and workflow management in accordance with project tracking tools.
Keep abreast of therapeutic area advances, evolving regulatory frameworks, and best practices in medical writing.
Provide technical mentorship, manage project timelines and budgets, and collaborate with cross-functional teams, sponsors, regulatory bodies, academia, and external data partners while ensuring compliance with evolving public health and regulatory standards.
Clinical Data Management: Lead eCRF design, data collection, entry, validation, query management, database testing (including UAT), and ensure timely delivery of clean,

📌 Senior Medical Writer Rwe Bengaluru
🏢 Trigent Software
📍 Bengaluru