Associate Director, Medical Writing (Regulatory)
About The Position
Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators. In 2012, we received FDA approval of Korlym® (mifepristone), the first approved treatment for hypercortisolism (Cushing’s syndrome). Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation. What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease. 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 a hybrid role typically requiring on-site presence at least 3 days per week.
Requirements
- 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
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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Ph.D. or professional degree
Number of Employees
251-500 employees
