Group Head, Regulatory Writing
- East Hanover, NJ
817 million, that's how many lives our products touched in 2018. While we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
To manage a team of medical writing associates within an the Regulatory Writing and Submissions (RWS) function. Collaborate with other RWS Group and Function Heads to coordinate the timely production of high quality deliverables.
• Functional and Operational Manager for a group of associates.
• Ensure high quality and timely delivery of tasks/projects assigned to gGroup.
• Responsible for project information flow (resources, status of assigned activities, issues) to teams and to Global/Unit Head.
• Interact with other Group and Function Heads to ensure proper prioritization of programs and assign adequate resources according to agreed strategy and timelines.
• 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.
• 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).
EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
• Advanced education/degree in life sciences/healthcare or equivalent work experience is preferred.
• 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
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