Job Description
Job Description
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 Drug Applications (NDAs).
- Serve as the primary point of contact for regulatory agencies during submissions and interactions.
- Drive initiatives to optimize processes and improve the efficiency of the regulatory writing function.
Requirements
Requirements :
- Advanced degree in Life Sciences, Medicine, or related field (PhD, MD preferred).
- 8+ years of regulatory medical writing experience, with a focus on oncology.
- Proven leadership experience in managing teams and projects in a fast-paced environment.
- In-depth understanding of regulatory requirements for drug development, particularly in oncology.
- Excellent communication skills, with the ability to convey complex information clearly and persuasively.
- Strong organizational skills, with a keen eye for detail and the ability to manage multiple priorities effectively.
- Ability to work collaboratively in a multidisciplinary team setting.
Benefits
- Very competitive Basic Salary
- Up to 22% 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
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