Director, Medical Writing Lead
hace 3 semanas
We are seeking an experienced Director, Medical Writing to drive the creation of high-quality clinical regulatory documents and support the development of our clinical portfolio.
Your Impact:- Strategize and Lead: Develop and execute document strategies for regulatory submission, ensuring the highest quality of clinical study protocols, reports, and Investigator's Brochures.
- Collaborate and Contribute: Play a key role in developing briefing packages and responses to health authority inquiries, contributing to global regulatory submission documents.
- Ensure Excellence: Author and manage outstanding medical writing deliverables, guaranteeing scientific accuracy, clarity, and compliance with regulatory and internal guidelines.
- Communicate Consistently: Support the development of uniform messaging across all submission documents, including nonclinical, clinical, and product labeling.
- Mentor and Direct: Mentor and Direct medical writing team members to ensure efficiency and quality in document production.
- Innovate and Collaborate: Develop effective partnerships within Mymenopauserx, Llc and with external stakeholders to maintain adherence to industry standards and regulatory requirements.
- Experience: At least 10 years of clinical regulatory medical writing experience, with global clinical trials and regulatory submissions expertise.
- Communication Skills: Exceptional oral and written communication abilities, with proficiency in MS Office.
- Regulatory Knowledge: A deep understanding of global regulatory requirements and ICH/GCP guidelines.
- Leadership: Proven experience managing and mentoring medical writers and fostering the development of junior staff.
- Professional Ethics: A strong sense of responsibility, ethics, and respect for others.
- Work Environment: Ability to work in an office environment, utilizing computers and participating in communication and collaborative activities during standard business hours.
- Flexible Health Benefits: a flexible benefits program for comprehensive health and dental care.
- Retirement Savings: Employees receive an automatic employer Pension contribution and can contribute to the Optional Savings Plan, which attracts an additional company match.
- Flexible Extras: We offer extras to support employees and the big moments in life.
- Vacation: a minimum of 4 weeks of paid vacation, pro-rated to your date of hire.
At Mymenopauserx, Llc, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives.
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