Medical Writing Director
hace 4 semanas
As a pivotal member of our team, you will drive the creation of high-quality clinical regulatory documents and support the development of our clinical portfolio. Your impact will be felt across the organization as you strategize and lead the development and execution of document strategies for regulatory submission, ensuring the highest quality of clinical study protocols, reports, and Investigator's Brochures.
Key Responsibilities:- Develop and execute document strategies for regulatory submission, ensuring scientific accuracy, clarity, and compliance with regulatory and internal guidelines.
- Collaborate with cross-functional teams to develop briefing packages and responses to health authority inquiries, contributing to global regulatory submission documents.
- Author and manage outstanding medical writing deliverables, guaranteeing scientific accuracy, clarity, and compliance with regulatory and internal guidelines.
- Support the development of uniform messaging across all submission documents, including nonclinical, clinical, and product labeling.
- Mentor and direct medical writing team members to ensure efficiency and quality in document production.
- At least 10 years of clinical regulatory medical writing experience, with global clinical trials and regulatory submissions expertise.
- Exceptional oral and written communication abilities, with proficiency in MS Office.
- A deep understanding of global regulatory requirements and ICH/GCP guidelines.
- Proven experience managing and mentoring medical writers and fostering the development of junior staff.
- A strong sense of responsibility, ethics, and respect for others.
- PhD or MS degree in life sciences or an advanced degree in a relevant field.
- Exceptional skills in establishing internal and external relationships, including with alliance partners and vendors.
- Proficiency in planning, budgeting, and project management, coupled with strong problem-solving and negotiation skills.
- Knowledge of rare and ultra-rare diseases is highly advantageous.
- Flexible Health Benefits: a flexible benefits program for comprehensive health and dental care
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