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:

• Master's degree in Life Sciences, Epidemiology, Public Health, Biostatistics; Bachelor's degree in Medicine, Pharmacy or a related field (Ph.D., PharmD or MD preferred).
• 3-5 years of professional experience in medical/scientific writing, applied epidemiology, and/or public health research within CRO, pharma, or academic settings.
• Strong understanding of medical and scientific concepts with proven ability to translate complex information into clear, concise content for diverse audiences.
• Excellent scientific writing, editing, and verbal communication skills with a high level of attention to detail.
• Proficiency in Microsoft Office Suite and reference management tools (e.g., EndNote, Zotero).
• Knowledge about statistical software (e.g., SAS, R, Python) and data visualization tools is an advantage.
• Ability to manage multiple projects, meet deadlines, and work both independently and collaboratively across teams.

Preffered attributes:

• Experience writing in specific therapeutic areas (oncology, neurology, rare diseases).

• Publication record in peer-reviewed journals or experience supporting manuscripts and congress materials.

• Experience in managing clinical research would be beneficial.