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 professionals.
- 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