Lead - Regulatory Writing

Role Overview: As a Lead Medical Writer, your role involves developing and reviewing medical writing deliverables that support the clinical regulatory writing portfolio. Additionally, you will be responsible for training junior writers. Key Responsibilities: - Author a variety of clinical document types supporting regulatory filings, including Module 2.3, 2.4, 2.5, 2.7, 5.2, clinical study reports (CSRs), protocols, Informed Consent Forms, amendments, and Investigator Brochures (IBs) - Exhibit excellence in focused writing and editing following defined processes and templates - Lead cross-functional teams in drafting scientific/medical content addressing data interpretation, product claims, and internal/external questions - Understand the clinical development process from program planning to submission, including clinical trial design - Demonstrate effective time management, organizational, and interpersonal skills - Maintain a customer-focused approach - Adhere to processes and best practices defined by the Sponsor - Facilitate review meetings, address feedback, and negotiate solutions/agreements - Coordinate and oversee work plans for individual and multiple-document delivery - Manage tasks, roles, responsibilities, and timing of the authoring team, contributors, and reviewers - Provide insight, alternatives, and suggestions based on previous experiences - Train writers/authors on the use of templates, guidelines, and tools - Conduct appropriate literature searches and screening as required - Share lessons learned and best practices with the team Qualifications Required: - Education: MBBS/PhD/MDS/BDS/MPharm/PharmD - Experience: 4 to 6 years in writing Clinical & Regulatory documents supporting global filings (CTD Module 2 and Module 5) - Strong knowledge of regulatory guidelines and requirements - Ability to interpret data and apply scientific knowledge to support regulatory document writing - Expert authoring skills in MS Word and experience with document management systems - Flexibility in adapting to new tools and technology *No additional details about the company were provided in the job description.*,