Associate Director of Regulatory Medical Writing
AL Solutions
Redwood City, california
Job Details
Not Specified
Full Job Description
Aramis Frost is partnering with a leading Biotech specializing in Oncology to find an Associate Director of Regulatory Medical Writing. In this pivotal role, you will oversee the regulatory writing strategy and contribute significantly to the development of cutting-edge oncology therapies. You will work closely with cross-functional teams to ensure timely and accurate submissions to regulatory authorities.
Key Responsibilities
- Lead the preparation and review of complex regulatory documents, including INDs, NDAs, and clinical study reports.
- Collaborate with project teams to develop writing strategies that align with clinical and regulatory objectives.
- Mentor and guide team members in best practices for regulatory writing and compliance.
- Maintain up-to-date knowledge of regulatory guidelines and industry trends specific to oncology.
- Engage with regulatory agencies as needed to facilitate the submission process.
Requirements
- Master's degree in Life Sciences, Medicine, or a related field (PhD or MD preferred).
- 7+ years of experience in regulatory medical writing, especially in the oncology sector.
- Ideally experience working in Biotechnology or pharmaceutical company - CRO and Consultancy can be considered
- Track record of successful regulatory submissions to FDA and EMA.
- Strong understanding of FDA/EMA guidelines and requirements for oncology.
- Excellent written and verbal communication skills, with a focus on clarity and precision.
- Demonstrated leadership and mentoring abilities.
- Ability to manage multiple projects simultaneously and meet strict deadlines.
- Willingness to participate in occasional travel for team meetings or regulatory engagements.
Benefits
- Very competitive Basic Salary
- Up to 18% 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