Group Head, Regulatory Writing
The Group Head, Regulatory Writing will manage a team of Regulatory Writing associates and collaborate with other RWS Groups and Function Heads to coordinate the timely production of high quality deliverables.
Major Responsibilities:
1. Functional and Operational Manager for a group of associates.
2. Oversee day-to-day operations for group of associates and ensure adequate staffing of programs.
3. Ensure high quality and timely delivery of tasks/projects assigned to Group.
4. Responsible for project information flow (resources, status of assigned activities, issues) to teams and to Global/Unit Head.
5. Interact with other Group and Function Heads to ensure proper prioritization of programs and assign adequate resources according to agreed strategy and timelines.
6. Identify issues and resource gaps for the preparation and delivery of the different documents; ensure resolution of issues including anticipation; negotiate and implement solutions in collaboration with other RWS Group and Function Heads.
7. Ensure adherence to internal policies and processes and to regulatory requirements.
8. Ensure effective development (development/training plans, Organizational Talent Review, coaching or mentoring, as appropriate) and performance (objectives setting, performance review and compensation planning) management of all assigned associates liaising with other Group and Function Heads, as appropriate.
9. Commitment to develop people, processes, innovation, and external focus.
10. Individual contributor within Line Function, as dictated by project needs and resource capacity, at corresponding individual contributor level (e.g., Senior Regulatory Writer, Senior Clinical Submission Manager).
Requirements:
Education: Advanced education/degree in life sciences/healthcare or equivalent work experience is required.
Language: Fluent English (oral and written).
• = 4 years' experience in clinical research with proven proficiency in global development.
• Advanced knowledge of and repeat experience in global registration of drugs (complex submissions).
• Advanced knowledge of and experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements).
• Solid leadership talent and negotiation skills.
• Team management experience with cross-functional and global responsibilities.
