Medical Writer

Trigent Software - Professional Services; Bengaluru; On-site; INR 1,000,000 - 1,500,000; Full time

Job summary

A leading software services firm is looking for a Senior Medical Writer to manage and author high-quality scientific documents. This role requires strong scientific understanding, writing expertise, and the ability to lead real-world evidence studies. The ideal candidate has a Master’s degree in a relevant field, 3–5 years of experience, and excellent communication skills. Join us to contribute to impactful projects in the healthcare sector.

Qualifications

• 3–5 years of experience in medical/scientific writing, applied epidemiology, or public health research.
• Proven ability to manage multiple projects and meet tight deadlines.
• Excellent writing, editing, and verbal communication skills with attention to detail.

Responsibilities

• Author, edit, and review scientific and regulatory documents.
• Design and lead real‑world data and epidemiological studies.
• Support regulatory submissions and deliver study reports.

Skills

Medical/scientific writing

Epidemiology

Public Health

Data management

Microsoft Office Suite

Statistical software

Education

Master’s degree in Life Sciences, Epidemiology, Public Health, or Biostatistics

Bachelor’s in Medicine, Pharmacy, or related fields

Tools

SAS

R

Python

EndNote

Zotero

Job description

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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.

Seniority level

Mid‑Senior level

Employment type

Full‑time

Job function

Writing/Editing, Health Care Provider, and Other

Industries

• Biotechnology Research
• Pharmaceutical Manufacturing
• Research Services