Medical Writing Director
hace 4 semanas
Empower the Future of Medicine at Mymenopauserx, Llc
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:
- Drive the development and execution of document strategies for regulatory submission
- Collaborate with cross-functional teams to develop briefing packages and responses to health authority inquiries
- 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
- Mentor and direct medical writing team members to ensure efficiency and quality in document production
What You Bring to the Table:
- 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
What We Offer:
- Flexible health benefits for comprehensive health and dental care
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