Job Title: Chief Manager – Medical Writer
Location: Mumbai, Maharashtra, India (Kurla)
Department: Regulatory Affairs
Business Unit: Piramal Critical Care (PCC)
Travel Requirement: Low
Reporting To: Vice President, Regulatory Affairs
Job ID: Not specified
Job Overview
Responsible for creating scientifically accurate and regulatory-compliant documents to support drug development, regulatory submissions, and medical communications. This role involves interpreting complex clinical data and translating it into clear content for various stakeholders including regulatory authorities, healthcare professionals, and internal teams.
Key Stakeholders
Internal: IT, Regulatory Affairs, Pharmacovigilance, Medical Information
External: Healthcare Professionals, Publications, IT Developers, Health Authorities
Essential Qualifications
Master’s or PhD in Life Sciences, Pharmacy (M.Pharm, B.Pharm), or Medicine (MBBS, BDS, MD)
MBBS or MD preferred
Certifications in medical writing (e.g., EMWA, AMWA, ISMPP) are a plus
Experience
3–5 years of experience in the pharmaceutical industry
Experience in regulatory affairs, medical affairs, or CROs
Familiarity with ICH, FDA, EMA, CDSCO guidelines
Experience in writing Company Core Data Sheets (CCDS)
Key Responsibilities
Regulatory Writing
Develop and review clinical study reports (CSRs), investigator brochures (IBs), CTDs, protocols, ICFs, and regulatory dossiers.
Scientific & Medical Writing
Create high-quality manuscripts, abstracts, white papers, literature reviews, and slide decks for publication or education.
Medical Communications
Develop product monographs, training materials, and KOL presentations for internal and external use.
Data Interpretation & Literature Review
Perform detailed reviews and analyze clinical/non-clinical data for drug development and post-marketing.
Compliance & Quality Assurance
Ensure alignment with global regulatory requirements (ICH-GCP, FDA, EMA, etc.) while maintaining accuracy and clarity.
Cross-functional Collaboration
Collaborate with teams including regulatory, clinical research, PV, and medical affairs for document development.
Competencies & Skills
Proficient in regulatory and clinical medical writing
Knowledge of drug development and clinical trial processes
Familiarity with referencing tools (EndNote, Mendeley)
Understanding of regulatory submission formats (eCTD, FDA, EMA)
Strong research, analytical, and communication skills
Proficient in Microsoft Office Suite (Word, PowerPoint, Excel)
About the Company
Piramal Critical Care (PCC), under Piramal Pharma Limited, is a global leader in hospital generics and one of the top producers of inhaled anaesthetics. With a presence in over 100 countries, PCC operates cutting-edge manufacturing units in India and the USA and focuses on sustainable, ethical, and inclusive growth.
Equal Opportunity Statement
Piramal Group is an equal opportunity employer. Employment decisions are based on qualifications, skills, and performance without regard to race, gender, religion, disability, or other protected characteristics.
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