What are the responsibilities and job description for the Associate Director, Medical Writing (Regulatory) position at Corcept Therapeutics?
The Associate Director, Medical Writing (Regulatory) will provide strategic and operational medical writing expertise to prepare high-quality clinical regulatory documents for Health Authority submissions. This position will collaborate across the organization to implement and maintain a standardized document development process for regulatory documents. This is an hybrid role typically requiring on-site presence at least 3 days per week.
Responsibilities:
- Develop and execute strategies for organizing and preparing documents for regulatory health authority submissions
- Plan, prepare, write, edit, format, and finalize regulatory documents including IND, CTA/IMPD, NDA, MAA, clinical and non-clinical summaries, updates to regulatory submissions, meeting requests, briefing books, annual reports/development safety update reports (DSURs)
- Oversee document preparation activities and track progress against targets; produce timely and accurate status update reports
- Provide oversight of document quality and consistency for ease of review across multiple documents assembled in a regulatory dossier or briefing package
- Lead document review and comment resolution processes with cross-functional teams
- Leverage scientific expertise to write, review, and edit science-based documents such as those included in IND/NDA sections, meeting requests, briefing books and annual reports
- Coordinate the review and approval of documents
- Develop templates, style guidelines, and SOPs for regulatory documentation
- Ensure final documents adhere to standard operating procedures (SOP), good clinical practice (GCP), and International Council on Harmonization (ICH) requirements
Preferred Education and Experience:
- JD/Paralegal degree with scientific background or advanced scientific degree (MS, PhD or PharmD)
- Regulatory medical writing experience in the pharmaceutical industry/CRO environment or equivalent experience writing technical materials for submission to regulatory authorities, legal entities and/or other audiences
- Able to compile, analyze, and present data clearly, concisely, and effectively
- Experience participating in submissions to the US FDA (IND, NDA) and EMA (MAA)
- Strong understanding of drug development and regulations (US, EU and ICH)
- Broad knowledge of relevant regulatory guidelines (e.g., FDA, EMA) and compliance requirements
- Proficiency with Electronic Common Technical Document (eCTD) templates
- Strong verbal and written communication skills to effectively collaborate with cross-functional teams and address regulatory queries
The pay range that the Company reasonably expects to pay for this headquarters-based position is $144,800 - $212,900; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full-time basis.
Salary : $144,800 - $212,900
