Medical Writer

1 day ago

Bengaluru, Karnataka, India Trigent Software - Professional Services Full time ₹ 12,00,000 - ₹ 24,00,000 per year

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.

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