Regulatory Medical Writing Team Lead
2 months ago
AL Solutions is seeking a highly motivated Director of Regulatory Medical Writing for a major Biotech company specializing in Oncology.
Key Responsibilities- Leadership and Team Management
- Lead a team of regulatory writers, providing guidance and mentorship to enhance their skills and ensure high-quality output.
- Develop and implement a regulatory writing strategy that aligns with the company's goals and objectives.
- Regulatory Writing and Compliance
- Oversee the development of critical documents, including Clinical Study Reports (CSRs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
- Ensure compliance with health authority guidelines and regulations.
- Cross-Functional Collaboration
- Collaborate with cross-functional teams, including clinical, safety, and medical affairs, to produce high-quality documents.
- Communicate effectively with regulatory agencies during submissions and interactions.
- Process Improvement
- Drive initiatives to optimize processes and improve the efficiency of the regulatory writing function.
- Identify areas for improvement and implement changes to enhance productivity and quality.
- Education and Experience
- Advanced degree in Life Sciences, Medicine, or related field (PhD, MD preferred).
- 8+ years of regulatory medical writing experience, with a focus on oncology.
- Leadership and Communication Skills
- Proven leadership experience in managing teams and projects in a fast-paced environment.
- Excellent communication skills, with the ability to convey complex information clearly and persuasively.
- Organizational and Technical Skills
- 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.
- Competitive Compensation and Benefits
- Very competitive Basic Salary.
- Up to 22% annual performance bonus.
- Stocks options and LTI programs.
- Work-Life Balance and Wellness
- Home office Allowance.
- Annual company offsite holiday.
- Mental health awareness - 8 company-paid therapy sessions a year.
- Professional Development and Growth
- Sports Club & Gym membership.
- 100% paid medical insurance.
- 401(k) program.
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Director of Regulatory Medical Writing
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