Senior Director of Regulatory Medical Writing
AL Solutions
Jersey City, new jersey
Job Details
Full-time
Full Job Description
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