Biocon Biologics is currently hiring Medical Writers in Bangalore, Karnataka, India. This opportunity is ideal for professionals with experience in regulatory medical writing, clinical documentation, and scientific data interpretation within the pharmaceutical or biotechnology industry.
The Medical Writer role at Biocon Biologics involves preparing regulatory and clinical documents aligned with global guidelines such as FDA, EMA, CDSCO, ICH, and CONSORT standards. The position requires collaboration with cross-functional teams including clinical research, regulatory affairs, and pharmacovigilance departments.
Candidates with strong scientific writing skills, regulatory knowledge, and clinical data interpretation experience can build a rewarding career in regulatory medical writing and clinical documentation within the rapidly growing biopharmaceutical sector.
Job Details
| Field | Details |
|---|---|
| Position | Medical Writer |
| Company | Biocon Biologics |
| Location | Bangalore, Karnataka, India |
| Job Type | Full-time |
| Work Mode | On-site |
| Department | Clinical Development / Regulatory Affairs |
| Industry | Biotechnology / Pharmaceutical |
Key Responsibilities
The Medical Writer at Biocon Biologics will be responsible for preparing high-quality regulatory and clinical documents while ensuring compliance with global regulatory standards.
Primary responsibilities include:
- Writing, editing, reviewing, formatting, and publishing regulatory and clinical documents.
- Preparing clinical and post-marketing regulatory dossiers aligned with FDA, EMA, CDSCO, ICH, and CONSORT guidelines.
- Collaborating with the clinical development team to support the Clinical Development Plan (CDP).
- Developing and maintaining Standard Operating Procedures (SOPs) for regulatory documentation.
- Interpreting and summarizing clinical trial data and scientific research findings.
- Planning, organizing, and tracking clinical and post-marketing regulatory submissions.
- Coordinating with cross-functional teams and global stakeholders.
- Managing documentation across the entire project lifecycle.
- Ensuring compliance with internal SOPs, regulatory policies, and industry guidelines.
- Developing expertise in scientific publications and regulatory writing.
- Training team members and mentoring junior staff when required.
Required Qualifications
Candidates applying for the Medical Writer job at Biocon Biologics should meet the following requirements:
- Degree in Pharmacy, Life Sciences, Biotechnology, or related fields.
- Experience in medical writing, regulatory writing, or clinical documentation.
- Strong understanding of global regulatory guidelines (FDA, EMA, CDSCO, ICH).
- Knowledge of clinical trial documentation and regulatory submissions.
- Ability to interpret and summarize scientific and clinical data.
- Excellent scientific writing, editing, and communication skills.
- Experience collaborating with clinical research, regulatory affairs, and pharmacovigilance teams.
Preferred skills:
- Experience with clinical study reports (CSRs), protocols, and regulatory dossiers.
- Knowledge of publication writing and regulatory submission frameworks.
Benefits of Working at Biocon Biologics
Employees working in medical writing roles at Biocon Biologics may receive several professional benefits:
- Opportunity to work in a leading global biopharmaceutical organization
- Exposure to international regulatory submissions
- Collaborative work environment with clinical research and regulatory experts
- Career growth in regulatory medical writing and clinical development
- Access to training programs and skill development initiatives
How to Apply
Application Link Throgh Naukri
