Medical Writer

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 Master’s degree in Life Sciences, Epidemiology, Public Health, or Biostatistics ; Bachelor’s in Medicine, Pharmacy, or related fields (Ph.D., PharmD, or MD preferred). 3–5 years of professional experience in medical/scientific writing, applied epidemiology, or public health research within CRO, pharmaceutical, or academic environments. Strong understanding of medical and scientific concepts with the ability to translate complex data into clear, concise documents. Excellent scientific writing, editing, and verbal communication skills with strong attention to detail. Proficient in Microsoft Office Suite and reference management tools (e.g., EndNote, Zotero ). Knowledge of statistical software (e.g., SAS, R, Python ) and data visualization tools is an advantage. Proven ability to manage multiple projects, meet tight deadlines, and work independently or collaboratively across teams. Preferred Attributes Experience writing in therapeutic areas such as Oncology, Neurology, or Rare Diseases . Track record of publications in peer-reviewed journals or experience supporting manuscripts and conference materials.