Visionary Leader for Medical Writing and Clinical Reporting
2 days ago
About the Role
We are seeking a visionary leader to spearhead our medical writing and clinical reporting function. As Director for Clinical Reporting, you will lead a team of 7 dedicated professionals, responsible for the global medical writing and clinical reporting function.
Your key responsibilities will include:
- Team Leadership: Manage the Clinical Reporting team, ensuring effective resourcing of projects and tasks to fulfill medical writing and clinical disclosure commitments.
- Employee Development: Set goals, develop training plans, and coach employees to achieve successful task execution.
- Collaboration: Coordinate activities with Global Clinical Development, Global Regulatory Affairs, Safety and Pharmacovigilance, Global Medical Affairs, and affiliate companies as necessary.
- Regulatory Compliance: Ensure timely execution of approved Clinical Development Plans and Regulatory Submission Plans.
- Public Disclosure: Coordinate global public disclosure activities for trials in ALK according to requirements.
- Publication Planning: Participate in publication planning activities and support development of publication plans.
About You
To succeed in this role, you will require:
- Relevant Education: A Master's degree or Ph.D. in a relevant field.
- Medical Writing Experience: At least 8 years of experience in medical writing, with a proven track record of delivering high-quality content.
- Leadership Skills: Proven experience in people management, with the ability to inspire, mentor, and develop your team.
- Regulatory Knowledge: Thorough knowledge of regulatory interactions, including EMA, US FDA, CA HC, CN CDE, or JP PMDA.
- Communication Skills: Fluency in spoken and written English, with exceptional communication and writing skills.
- IT Skills: Experienced user of IT systems.
About ALK-Abello
ALK-Abello is a global pharmaceutical company specializing in allergy immunotherapy. We offer a dynamic work environment that fosters personal and professional growth. Our teams value collaboration, innovation, and integrity, and we strive to create an inspiring and fun workplace. If you're passionate about leadership, medical writing, and clinical reporting, and want to join a talented team that makes a real difference, we encourage you to apply.
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