Advertisement
Are you a skilled medical writer with experience in clinical trials and regulatory documentation?
Macleods Pharmaceuticals Ltd., one of India’s leading pharmaceutical companies, is hiring an experienced Medical Writing Professional for its Clinical Trials Department.
This full-time role is ideal for professionals who can manage multiple complex projects, deliver high-quality scientific documents, and ensure compliance with global regulatory standards.
Key Responsibilities
As a Medical Writer – Clinical Trials, your responsibilities include:
Advertisement
- Writing, reviewing, and editing clinical and regulatory documents, including:
- Clinical Study Protocols and Appendices
- Case Record Forms (CRFs)
- Informed Consent Documents (ICDs)
- Patient Information Sheets (PIS)
- Investigator’s Brochures (IB)
- Clinical Study Reports (CSR)
- Manuscripts and Regulatory Modules (IND, NDA, BLA, CTA)
- Performing literature reviews and extracting data from scientific databases.
- Conducting final QC checks, formatting, and version control of documents.
- Applying knowledge of ICH-GCP guidelines and clinical trial regulations.
- Collaborating with internal and external stakeholders for timely feedback.
- Developing templates, style guides, and SOPs for medical writing activities.
- Participating in audits and quality reviews as required.
Qualifications and Experience
- Qualification: Ph.D., Pharm.D., M.Pharm, B.H.M.S., or B.A.M.S.
- Experience: Minimum 6 years in clinical research or medical writing.
- Proven ability to handle at least three complex projects simultaneously.
- Strong understanding of clinical development, scientific writing, and regulatory submissions.
- Excellent command of English grammar, scientific terminology, and data presentation.
Why Join Macleods Pharma?
- Work in a globally recognized pharmaceutical R&D organization.
- Exposure to end-to-end clinical documentation and regulatory submissions.
- Opportunity to collaborate with a multidisciplinary scientific team.
- Competitive salary and benefits package aligned with industry standards.
Job Details
- Company: Macleods Pharmaceuticals Ltd.
- Position: Medical Writer – Clinical Trials
- Department: Clinical Trials Department
- Location: Mumbai, Maharashtra, India
- Experience: 6+ years
- Reporting to: AGM – Clinical Trials
- Employment Type: Full-time, On-site
- Expected Salary: ₹9,00,000 – ₹15,00,000 per annum (depending on experience)
How to Apply
Interested candidates can send their updated CVs to:
📧 adityab@macleodspharma.com
Advertisement
