Senior Medical Writer-RWE

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, reliable datasets through interim reviews and database lock.
• Quality and Compliance : Prepare DMPs / DVPs, implement edit checks and reconciliation procedures, coordinate with cross-functional teams and vendors, and maintain compliance with GCP, ICH, and 21 CFR Part 11 while driving process improvements.

Qualifications :

Preffered attributes :