Chief Medical Writer Job at Piramal in Mumbai, Apply Now!
Looking to take your medical writing career to the next level? Piramal Critical Care is hiring a Chief Manager – Medical Writer in Kurla, Mumbai. This mid-level role is ideal for life sciences professionals with 3–5 years of experience in regulatory or medical affairs. Collaborate with cross-functional teams to develop high-impact, regulatory-compliant documents that support drug development, submissions, and communications—all while making a global impact.
The ideal candidate will be responsible for developing scientifically accurate and regulatory-compliant medical and clinical documents to support drug development, regulatory submissions, and medical communications. This role requires a deep understanding of medical and pharmaceutical concepts, strong analytical skills, and the ability to translate complex clinical data into clear and concise content for different stakeholders, including regulatory agencies, healthcare professionals, and internal teams.
Reports to: Vice President, Regulatory Affairs
- Master’s or PhD in Life Sciences, Pharmacy (M.Pharm, B.Pharm), Medicine (MBBS, BDS, MD), or a related field. MBBS or MD preferred.
- Additional certifications in medical writing (e.g., EMWA, AMWA, ISMPP) are a plus.
- Mid-level: 3-5 years of experience in the pharmaceutical industry.
- Prior experience in regulatory affairs, medical affairs, or clinical research organizations (CROs).
- Knowledge of ICH, FDA, EMA, and CDSCO guidelines.
- Experience in writing Company Core Data Sheets (CCDS) for drug products.
- Regulatory Writing: Prepare and review clinical study reports (CSRs), investigator brochures (IBs), common technical documents (CTDs), protocols, informed consent forms (ICFs), and regulatory dossiers for drug approvals.
- Scientific & Medical Writing: Develop high-quality manuscripts, abstracts, white papers, literature reviews, and slide decks for conferences, publications, and medical education.
- Medical Communications: Create content for medical affairs, healthcare professionals, and marketing teams, including product monographs, training materials, and key opinion leader (KOL) presentations.
- Data Interpretation & Literature Review: Conduct comprehensive literature reviews and analyze clinical and non-clinical data to support drug development and post-marketing activities.
- Compliance & Quality Assurance: Ensure all content aligns with ICH-GCP, EMA, FDA, and other global regulatory guidelines, while maintaining accuracy, clarity, and consistency.
- Cross-functional Collaboration: Work closely with regulatory, clinical research, pharmacovigilance, and medical affairs teams to develop well-structured and scientifically sound documents.
- Strong command of medical and scientific writing, with a focus on regulatory and clinical documentation.
- Understanding of drug development, clinical trials, and Medical Affairs
- Proficiency in referencing and citation management tools (e.g., EndNote, Mendeley).
- Familiarity with regulatory submission formats (eCTD, FDA, EMA).
- Excellent research and analytical skills with attention to detail.
- Strong communication and teamwork abilities.
- Proficiency in Microsoft Office Suite (Word, PowerPoint, Excel).
Keywords: Piramal, Medical Writer, Regulatory Affairs, Medical Communications, Clinical Documents, Drug Development
