Biocon Biologics Medical Writer Jobs

Biocon Biologics Hiring Medical Writer in Bengaluru | Pharmacy & Life Sciences Professionals Apply

Biocon Biologics has announced an exciting opportunity for Medical Writer professionals at its Bengaluru location. The company is looking for candidates with expertise in regulatory writing, clinical documentation, scientific communication, and dossier preparation to support global regulatory submissions and clinical development programs.

This role offers exposure to regulatory documentation, clinical study reports, investigator brochures, Common Technical Document (CTD) modules, scientific data interpretation, and AI-enabled medical writing processes. Candidates with backgrounds in Pharmacy, Life Sciences, Biotechnology, Clinical Research, and Regulatory Affairs can explore this opportunity to build a rewarding career in pharmaceutical regulatory writing and clinical development.

Company Overview

Biocon Biologics is a global biosimilars and biologics company committed to expanding access to affordable, high-quality biologic therapies worldwide. As a subsidiary of Biocon Ltd., the company focuses on developing, manufacturing, and commercializing biosimilars, novel biologics, and advanced therapies across multiple therapeutic areas.

With a strong presence in international markets, Biocon Biologics operates according to global regulatory standards and collaborates with healthcare organizations, regulatory agencies, and research partners worldwide.

Job Role & Responsibilities

Regulatory Medical Writing

• Write, edit, review, format, and publish regulatory documents.
• Prepare clinical and post-marketing regulatory documentation.
• Develop and review regulatory dossier sections.
• Ensure compliance with FDA, EMA, CDSCO, ICH, CONSORT, and other global regulatory guidelines.

Clinical Development Support

• Collaborate with clinical teams in developing Clinical Development Plans.
• Support regulatory strategy and scientific communication activities.
• Assist in preparing Standard Operating Procedures (SOPs) related to regulatory documentation.

Scientific Data Interpretation

• Interpret and summarize clinical and scientific data.
• Develop scientific narratives and regulatory justifications.
• Present complex medical information in a clear and concise format.

Regulatory Dossier Management

• Plan and organize regulatory submission activities.
• Track and archive clinical and post-marketing dossiers.
• Manage document lifecycles from initiation through submission and archival.

Cross-Functional Collaboration

• Work closely with Regulatory Affairs, Clinical Development, Pharmacovigilance, Biostatistics, Medical Affairs, and Quality teams.
• Coordinate with stakeholders across different functions and geographies.
• Support global regulatory submission projects.

AI-Enabled Medical Writing Activities

• Utilize AI-powered drafting tools for first-pass document generation.
• Support preparation of Clinical Study Reports (CSRs).
• Contribute to Investigator Brochures (IBs).
• Assist with CTD Module 2.5, 2.7, and Module 5 documentation.
• Validate AI-generated content against source data and regulatory requirements.

Literature Review & Evidence Synthesis

• Conduct scientific literature reviews.
• Support citation management and evidence synthesis activities.
• Perform risk-benefit assessments and safety evaluations.
• Utilize AI-enabled research platforms for scientific analysis.

Team Development

• Train and support team members in regulatory writing practices.
• Share knowledge on scientific communication and documentation standards.
• Mentor junior colleagues when required.

Eligibility / Qualifications

Educational Qualification

Candidates should possess qualifications in Pharmacy, Life Sciences, Biotechnology, Clinical Research, or related scientific disciplines.

Eligible educational backgrounds include:

B.Pharm, M.Pharm, Pharm D, MSc Life Sciences, MSc Biotechnology, MSc Microbiology, MSc Biochemistry, Clinical Research, Pharmaceutical Sciences, Regulatory Affairs, Biomedical Sciences, Biotechnology, Molecular Biology, Pharmacology, Pharmaceutics, Pharmaceutical Analysis, Pharmaceutical Chemistry, and related disciplines.

Experience Required

• Experience in Medical Writing, Regulatory Writing, Clinical Documentation, or Scientific Writing.
• Experience supporting regulatory submissions and clinical development projects preferred.
• Knowledge of global regulatory guidelines and submission processes is advantageous.

Required Skills

• Regulatory Medical Writing
• Scientific Writing
• Clinical Research Documentation
• Regulatory Affairs
• Clinical Development
• Dossier Preparation
• CTD Documentation
• Data Interpretation
• Scientific Communication
• Literature Review
• Project Management
• Stakeholder Management

Technical Skills

• Microsoft Word
• Microsoft Excel
• Microsoft PowerPoint
• Document Management Systems
• Regulatory Submission Platforms
• AI-Based Writing Tools
• Reference Management Software

Regulatory Knowledge

Candidates with knowledge of the following regulations will be preferred:

• FDA
• EMA
• CDSCO
• ICH Guidelines
• CONSORT Guidelines
• Global Regulatory Submission Standards

Location & Salary

Location: Bengaluru, Karnataka

Salary: ₹8 LPA – ₹16 LPA (Approximate Industry Standard Based on Experience and Expertise)

Application Process

Interested candidates can apply through the official LinkedIn job posting.

Apply Here: https://www.linkedin.com/jobs/view/4421904778/

Frequently Asked Questions (FAQs)

1. What qualifications are required for the Medical Writer role at Biocon Biologics?

Candidates with B.Pharm, M.Pharm, Pharm D, MSc Life Sciences, Biotechnology, Clinical Research, Regulatory Affairs, and related scientific qualifications are eligible.

2. What type of documents will the selected candidate prepare?

The role involves Clinical Study Reports (CSRs), Investigator Brochures (IBs), CTD modules, regulatory dossiers, scientific summaries, and post-marketing regulatory documents.

3. Is knowledge of regulatory guidelines required?

Yes. Familiarity with FDA, EMA, CDSCO, ICH, and CONSORT guidelines is highly desirable.

4. What AI-related responsibilities are included in this role?

The candidate will utilize AI-powered drafting tools, literature review platforms, evidence synthesis systems, and analytics tools to support regulatory writing activities.

5. Where is the job located?

The position is based in Bengaluru, Karnataka.

6. What is the expected salary range?

Based on current industry standards, Medical Writers with relevant experience can expect approximately ₹8 LPA to ₹16 LPA depending on expertise and experience.

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Job Summary

Category	Details
Company	Biocon Biologics
Department Vacancies	Medical Writer
Qualification	B.Pharm, M.Pharm, Pharm D, MSc, Biotechnology, Clinical Research, Life Sciences and Related Disciplines
Experience	Medical Writing / Regulatory Writing Experience Preferred
Location	Bengaluru, Karnataka

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