Scientific Writing and Reporting Scientist - Hyderabad

Document Authoring & Facilitation: Author, coordinate, and facilitate the timely review and approval of Phase I clinical and regulatory documents under supervision, including Clinical Study Reports (CSRs), protocols, and Common Technical Document (CTD) submission summary documents.

Cross-Functional Collaboration: Attend document planning and review meetings, interacting closely with Clinical Pharmacology TA Project Leads, Clinical Pharmacology Leaders, PK Scientists, and cross-functional teams on content strategy and writing best practices.

Timeline & Process Management: Establish document timelines and writing strategies in alignment with internal processes, acting as the primary point of contact for assigned scientific writing activities across various therapeutic areas.

Quality Control & Compliance: Perform quality control (QC) reviews of Phase I clinical and regulatory documents (protocols and CSRs) created within the department to ensure rigorous accuracy and adherence to company SOPs, templates, and ICH regulatory guidelines.

Clinical Pharmacology Integration: Interpret, summarize, and present medical and statistical findings from Clinical Pharmacology studies clearly and accurately.

Regulatory Compliance: Apply knowledge of regulatory guidance documents, international regulations, and ICH guidelines to all clinical documentation workflows.

Tools & Systems: Utilize advanced features in MS Word and designated company systems for time reporting, document management, and training compliance.

Ownership & Value Delivery: Demonstrate high learning agility, self-development, and accountability in executing assigned tasks to drive impactful delivery across global study teams.

Stakeholder Engagement: Build and maintain productive global working relationships across time zones, maintaining flexibility to align with international project schedules.

Global Organization: Exposure to cutting-edge research and career advancement within Johnson & Johnson's Innovative Medicine and MedTech ecosystem.

Hybrid Work Culture: Flexible hybrid working pattern with minimal travel requirements (~5%).