Senior Director of Regulatory Medical Writing

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 and industry standards for medical writing.
• Develop and maintain strong relationships with regulatory authorities.

Requirements

• Advanced degree in Life Sciences, Medicine, or related field (PhD, MD preferred).
• 10+ years of experience in regulatory medical writing, with a focus on Oncology.
• Proven leadership experience, managing teams and influencing cross-departmental initiatives.
• In-depth understanding of regulatory guidelines and processes for drug development.
• Strong communication skills, both written and verbal, with the ability to articulate complex information clearly.
• Exceptional project management skills, with the ability to prioritize multiple tasks effectively.
• Ability to work in a fast-paced environment and adapt to changing priorities.
• Willingness to travel occasionally to site team

Benefits

• Very competitive Basic Salary
• Up to 25% annual performance bonus
• Stocks options and LTI programs
• Home office Allowance
• Annual company offsite holiday
• Mental health awareness - 8 company-paid therapy sessions a year
• Sports Club & Gym membership
• 100% paid medical insurance
• 401(k) program