Advertisement
Primus Global is hiring experienced Regulatory / Medical Writers (Drugs) for a hybrid work model across major metro cities in India. This opportunity is ideal for professionals with strong expertise in clinical and regulatory document authoring for pharmaceuticals (non–medical devices).
If you have hands-on experience in CSRs, CTD Modules 2 or 5, protocols, ICFs, and Investigator Brochures, this role offers long-term growth, exposure to global submissions, and flexible working arrangements.
Job Highlights
- Role: Regulatory / Medical Writer (Drugs)
- Work Mode: Hybrid
- Experience Required: 4–10 years (relevant)
- Locations: Bangalore, Hyderabad, Pune, Mumbai, Delhi NCR
- Industry: Pharmaceuticals / Clinical Research
- Education: Master’s Degree / Pharm.D / Ph.D.
Key Responsibilities
- Author and review clinical regulatory documents including:
- Clinical Study Reports (CSRs)
- Clinical trial protocols and amendments
- Informed Consent Forms (ICFs)
- Investigator Brochures (IBs)
- Prepare and support CTD Module 2 and/or Module 5 documentation
- Ensure documents comply with ICH-GCP, regulatory guidelines, and sponsor standards
- Collaborate with cross-functional teams including clinical, regulatory, and medical affairs
- Support global regulatory submissions (IND, NDA, ANDA where applicable)
- Maintain version control, timelines, and quality standards
Eligibility & Qualifications
- Education: Master’s degree in Life Sciences/Pharmacy, Pharm.D, or Ph.D.
- Experience: 4–10 years in regulatory or medical writing (pharma domain)
- Strong hands-on experience with clinical document authoring
- Working knowledge of ICH guidelines and regulatory frameworks
- Excellent scientific writing, review, and communication skills
- Experience with drug development documentation (non-medical devices)
Salary & Benefits
- Estimated Salary Range: ₹8,00,000 – ₹18,00,000 per annum (based on experience)
- Hybrid work flexibility
- Exposure to global regulatory projects
- Career growth in regulatory and medical writing
- Collaborative and professional work environment
How to Apply
Interested and eligible candidates are requested to share their updated CV at the email ID below:
Advertisement
Tip from Pharmabharat: Highlight your experience with CSRs, CTD Modules, and regulatory submissions to improve shortlisting chances.
Advertisement
