Lead - Scientific Writing

Role Overview: You will be responsible for handling complex Medical Writing projects, providing review support for medical writing deliverables, training junior writers, and authoring a broad set of different clinical document types that support regulatory filings. Your role will also involve leading cross-functional teams, understanding the clinical development process, and possessing effective communication, time management, organizational, and interpersonal skills. Key Responsibilities: - Prepare and review clinical study reports, protocols, investigator brochures, submission documents, and other regulatory documents on investigational drugs in various stages of clinical development. - Apply lean authoring principles, coordinate document review activities, develop project plans, and work as an active member of cross-functional teams representing Medical Writing. - Conduct literature searches, participate in department initiatives, research regulatory requirements, and ensure compliance with company training. - Demonstrate excellence in focused/lean writing, lead cross-functional teams, understand the clinical development process, and possess effective communication, time management, organizational, and interpersonal skills. - Manage messaging for consistency, provide insight based on previous experiences, and train writers/authors on the use of templates, guidelines, and tools. Qualifications Required: - MBBS/PhD/MDS/BDS/MPharm/PharmD education qualification. - 10 to 12 years of experience in writing Clinical & Regulatory documents supporting global filings (CTD Module 2 and Module 5). - Strong knowledge of regulatory guidelines/requirements, the ability to interpret data, apply scientific knowledge to support regulatory document writing, and adaptability to new tools and technology. - People management experience for more than 2 years is required.,