Job Title

Education: MBBS/PhD/MDS/BDS/MPharm/PharmD Experience: 6-10 years in writing Clinical & Regulatory documents for global filings (CSR, CSP, CTD Module 2, and Module 5)Role Purpose: The Lead Medical Writer will develop and review medical writing deliverables that support the clinical regulatory writing portfolio and provide training to junior writers.Skills Required: - Experience in authoring various clinical document types for regulatory filings, with a preference for Module 2.4, 2.5, 2.7, 5.2, clinical study reports (CSRs), protocols, amendments, and Investigator Brochures (IBs) - Excellence in focused writing and editing, adhering to defined processes and templates - Ability to lead cross-functional teams in drafting scientific and medical content that addresses data interpretation, product claims, and internal/external inquiries - Understanding of the clinical development process from program planning to submission, including clinical trial design - Strong communication skills suitable for a professional environment - Effective time management, organizational, and interpersonal skills - Customer-focused approach - Comfort in following directions, templates, and structured processes for document delivery - Capability to work independently while maintaining communication with the Sponsor’s Medical Writing project manager - Flexibility to support business continuity across Therapeutic Areas - Proficiency in developing, coordinating, and overseeing work plans for individual and multiple-document delivery, ensuring all tasks, timelines, and responsibilities are clearly defined - Ability to manage tasks, roles, responsibilities, and timing of the authoring team, internal/external contributors, and reviewers to facilitate document completion - Adherence to processes and Sponsor-defined best practices - Skill in facilitating review meetings, addressing feedback, and negotiating solutions/agreements