Senior Medical Writer/ Medical Writer(3-5 Years)

5 days ago

Bengaluru, Karnataka, India Trigent Software Inc Full time ₹ 9,00,000 - ₹ 12,00,000 per year

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.

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