Associate Director, Clinical & Regulatory Medical Writing

Our client, a leading oncology mid-sized pharma company, is seeking to recruit an experienced and hands-on medical writer to join their team remotely. As an Associate Director of Medical Writing, you'll play a critical role in drug development by providing leadership on clinical and regulatory documents.

Key Responsibilities:

1. Lead authorship: The successful candidate will have extensive experience working as lead authors on Common Technical Document (CTD), Investigational New Drug Application (INDA), Biologics License Applications (BLAs), and New Drug Applications (NDAs). We are looking for someone with 8+ years' experience.
2. Hands-On Experience: You should be able to demonstrate that your previous work has been mostly hands-on and not just supervisory or managerial responsibilities.
3. Sector Knowledge: Experience within Pharma/Biotech/CROs. Experience in oncology is required.
4. Educational Qualification: Ph.D./MD/MS degree holders preferred; however, education can vary based upon prior relevant industry skill set/experience.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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