Head Regulatory Writing

Key responsibilities:

• Oversee business and operational management of the local Regulatory Writing (RW) team.

• Ensure quality, timeliness, efficiency, and scientific standards for all written documents, including Clinical Study Reports (CSR), Common Technical Document submissions, and other regulatory documents.

• Act as a documentation consultant to other line functions within GDD-J and beyond.

• Lead the development of document templates and documentation-related processes in close collaboration with global counterparts.

• Participate in priority setting, workload distribution, and resource planning to ensure optimal assignment of writing resources.

• Coordinate outsourcing of RW activities, acting as a liaison between internal vendor management and internal customers.

• Contribute to the development of the RW organization through collaboration within the management team and across functions.

• Recruit, develop, and manage performance of team members, including setting objectives and planning compensation.

• Identify training needs, coach, mentor, and train less experienced writers to foster high performance.

• Maintain compliance with audits, SOPs, and training requirements.

• Ensure timely reporting of adverse events, technical complaints, and compliance issues in accordance with company procedures.

Essential requirements:

• University degree in life sciences or equivalent; advanced degree preferred.

• At least 8 years of medical writing or relevant pharmaceutical industry experience, with strong scientific and regulatory knowledge.

• Expert knowledge of global regulatory environments, processes, and key regulatory bodies.

• Demonstrated experience in Japan local drug registration.

• Fluent in Japanese and English (oral and written).

• Excellent written, verbal, and presentation skills.

• Proven ability to prioritize and manage multiple projects.

• Strong problem-solving skills and ability to define and resolve complex issues.

• Experience managing global, cross-functional teams or complex projects in Japan.

• Demonstrated ability to motivate, coach, and develop people.

Desirable requirements:

• Advanced degree in life sciences/healthcare.

• Experience in matrix management and cross-functional process improvement.

Benefits and Rewards

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Commitment to Diversity and Inclusion

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Accessibility and Accommodation

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