Senior Director of Regulatory Medical Writing in 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...