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 report directly to the VP, Regulatory Affairs and will collaborate across the organization to implement and maintain a standardized document development process for regulatory documents.
Responsibilities:
- Plan, prepare, write, edit, format, and finalize regulatory documents including IND, CTA, clinical and non-clinical summaries, clinical protocols, clinical study reports, Investigator brochures, updates to regulatory submissions, 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; documents as well as consistent style to ease of review across multiple documents assembled in a regulatory dossier or briefing package
- Lead document review and comment resolution meetings with cross-functional teams;
- Leverage scientific expertise to write, review, and edit science-based reports such as the clinical protocol, Investigator’s Brochure, clinical study report, informed consent, risk/benefit analysis and integrated summary, IND sections, Briefing Documents and annual reports
- Develop and execute strategies for organizing and preparing documents for regulatory health authority submissions
- Coordinate the review and approval of documents
- Develop templates, style guidelines, and SOPs for clinical 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:
- BA/BS degree in a scientific field required; advanced scientific degree (PhD, PharmD, or MS) preferred
- 8 years of regulatory medical writing experience in the pharmaceutical industry or CRO environment
- Experience participating in submissions to the US FDA (IND, BLA) and EMA (MAA)
- Able to compile, analyze, and present data clearly, concisely, and effectively.
- Strong understanding of drug development, clinical study design, regulations (FDA and EU), ICH and scientific principles
- Broad knowledge of EMA/ICH guidelines and FDA guidance beyond those pertaining to specific regulatory documents
- Proficiency with Electronic Common Technical Document (eCTD) templates
The pay range that the Company reasonably expects to pay for this headquarters-based position is $181,000 - $213,000; 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 : $181,000 - $213,000
