Lead - Regulatory Writing

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 Sponsors 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