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).
- 35 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.
