Medical Writer

Position: Senior Medical Writer – RWELocation: BangaloreJob Type: Full-timeDepartment: Medical Writing – MCAPLJob DescriptionThe 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.