JOB DESCRIPTION

Position: Scientific Writing Associate

Department: Scientific and Regulatory Affairs

Location: Bengaluru, Karnataka (On- Site)

Reporting To: Manager, Scientific and Regulatory Affairs

Role Overview:

Medical Writer/ Scientific Writing Associate with experience to develop, review, and manage high-quality clinical and regulatory documentation in compliance with applicable guidelines and standards.

Key Responsibilities:

· Prepare, format, edit, and quality-check scientific and clinical research documents, including- study synopsis, study protocols, Clinical Study Reports (CSRs), Investigator brochures, Statistical Analysis Plans (SAPs), Manuscripts and publications, Abstracts, posters, and presentations, Informed Consent Forms (ICFs), Case Report Forms (CRF), Regulatory submission documents.

· Review documents for scientific accuracy, consistency, completeness, grammar, and adherence to company standards.

· Ensure documents are aligned with protocol requirements, study objectives, and regulatory guidelines.

· Contribute to SOP development, revision, and implementation.

· Develop, maintain, and update related templates, forms, checklists, logs, and standard document formats.

· Ensure controlled documents are current, approved, and available to project teams.

· Support implementation and continuous improvement of documentation processes.

· Maintain document repositories.

· Ensure compliance with applicable regulations and guidelines (e.g., ICH-GCP, applicable ISO guidelines, CDSCO, MDR 2017, NDCT 2019).

· Assist in audit and inspection readiness activities.

· Maintain meeting minutes, project trackers for all scientific writing deliverables.

· Track document progress, review status, comments reconciliation, and approval workflows.

· Track key milestones, deliverables,



and study timelines.

· Identify potential delays and proactively escalate risks to project stakeholders.

· Provide regular status updates and project reports.

· Coordinate with medical writers, biostatisticians, clinical teams, project managers, and subject matter experts.

· Schedule review meetings, collect feedback, and facilitate resolution of review comments.

· Follow up with medical writing and statistical consultants to ensure timely completion of deliverables.

· Compile, organize, and maintain source information required for document development.

· Ensure consistency across protocols, SAPs, reports, publications, and related study documents.

· Perform literature review and reference management activities.

· Assist in preparation and submission of manuscripts, abstracts, posters, and conference materials.

· Track publication-related activities and submission timelines.

· Support vendor and consultant management activities related to scientific writing projects.

· Ensure effective communication among cross-functional teams.

Qualifications & Skills:

- Bachelor's or Master’s degree in Life Sciences, Pharmacy, Medicine, or a related field.
- 2-5 years of experience in clinical research, medical writing with regulatory focus.
- Solid understanding of GCP (Good Clinical Practice) guidelines, other necessary guidelines and applicable regulatory requirements.




- Demonstrated knowledge and/or experience in research methodology, statistical analysis, and scientific literature searching and review.
- Strong knowledge of clinical research and regulatory requirements (India and/or global).
- Excellent scientific writing, written communication and attention to detail.
- Good command over English language, communication and interpersonal skills for effective interaction with the regulatory personnel and stakeholders.
- Experience in preparation and maintenance of the study documentation and regulatory submission forms.
- Strong analytical to interpret clinical and regulatory data and develop accurate, compliant documentation and submission dossiers.
- Detail-oriented with strong organizational and problem-solving skills.
- Ability to manage multiple tasks including multiple documents preparation/ review, projects, and timelines efficiently in a fast-paced research environment.

About Trial Guna Private Limited:

Trial Guna Private Limited (TGPL) is a Clinical Research Organization (CRO) committed to advancing innovative research solutions. We specialize in conducting high-quality, ethically compliant clinical trials that contribute to the development of effective medical treatments. At TGPL, we foster a dynamic and collaborative work environment that encourages professional growth and excellence.

We look forward to welcoming a dedicated professional to our team who shares our passion for clinical research excellence.

Interested to join us share your CV at [email protected]

Pay: ₹500,000.00 - ₹600,000.00 per year

Benefits:

- Cell phone reimbursement
- Flexible schedule
- Health insurance
- Internet reimbursement
- Leave encashment
- Paid sick time
- Paid time off
- Provident Fund

Work Location: In person

📌 Scientific Writing Associate (Bengaluru)
🏢 TrialGuna
📍 Bengaluru