Senior Director of Regulatory Medical Writing
AL Solutions
Jersey City, new jersey
Aramis Frost is seeking a Senior Director of Regulatory Medical Writing specializing in Oncology, to join our exclusive Biotech partner. As a key leader, you will manage and mentor a talented team of regulatory writers and serve as an SME contact for regulatory submissions and strategy. This role offers the unique opportunity to impact oncology programs that make a significant difference in patients' lives.
Responsibilities
- Lead and oversee the regulatory writing strategy for Oncology submissions to health authorities.
- Manage a team of regulatory medical writers, providing mentorship and professional development.
- Collaborate with cross-functional teams to align writing efforts with clinical development and regulatory strategies.
- Act as a primary author for crucial regulatory documents, including Investigational New Drug (IND) applications and New Drug Applications (NDA).
- Ensure compliance with regulatory requirements...