Director of Regulatory Medical Writing
AL Solutions
Lexington, massachusetts
AL Solutions is seeking a highly motivated Director of Regulatory Medical Writing for a major Biotech company specializing in Oncology. In this leadership role, you will be responsible for overseeing a team of regulatory writers while ensuring the quality and accuracy of pivotal documents required for regulatory submissions. Your expertise will directly contribute to advancing Oncology programs that are set to make a significant impact on patient outcomes.
Key Responsibilities:
- Lead the regulatory writing team, mentoring and guiding members to enhance their skills and ensure high-quality output.
- Take charge of the overall regulatory writing strategy for Oncology submissions, ensuring compliance with health authority guidelines.
- Collaborate with cross-functional teams, including clinical, safety, and medical affairs, to produce critical documents such as Clinical Study Reports (CSRs), Investigational New Drug (IND) applications, and New...