Chief Manager Medical Writer Piramal Pharma Solutions

About Piramal Pharma Solutions

Job Description

Business: Piramal Critical Care Department: Regulatory Affairs Location: Kurla, Mumbai Travel: Low Job Overview 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. Key Stakeholders: Internal Information Technology, Regulatory Affairs, Pharmacovigilance, Medical Information Key Stakeholders: External Healthcare Professional, Publications, IT Developers, Health Authorities Reporting Structure Reports to: Vice President, Regulatory Affairs Essential Qualification Masters 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. Experience 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. Role & Responsibilities 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. Competencies 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).,