Associate Director, Medical Writing (Regulatory)

Corcept Therapeutics

2+ years

USD 200,000 - 250,000

Redwood City

10 March 3, 2025

Job Description

Job Type: Full Time Education: MS/PhD/PharmD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Associate Director, Medical Writing (Regulatory)

Location: Redwood City, Hybrid
Company: Corcept Therapeutics
Salary: USD 200,000 - 250,000

Job Description:
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 requiring on-site presence at least three 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, and annual reports/DSURs.
Oversee document preparation activities and track progress against targets, producing timely and accurate status update reports.
Ensure document quality and consistency for ease of review across multiple documents in regulatory dossiers or briefing packages.
Lead document review and comment resolution processes with cross-functional teams.
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 SOPs, Good Clinical Practice (GCP), and International Council on Harmonization (ICH) requirements.

Preferred Qualifications:

JD/Paralegal degree with a scientific background or an advanced scientific degree (MS, PhD, or PharmD).
Regulatory medical writing experience in the pharmaceutical industry or CRO environment.
Experience participating in submissions to the US FDA (IND, NDA) and EMA (MAA).
Strong understanding of drug development regulations (US, EU, and ICH).
Knowledge of regulatory guidelines (e.g., FDA, EMA) and compliance requirements.
Proficiency with Electronic Common Technical Document (eCTD) templates.
Strong verbal and written communication skills to collaborate with cross-functional teams and address regulatory queries.

Compensation:
The company expects to pay between $144,800 - $212,900 for this position, with final pay depending on location, experience, and qualifications.

Note: Applicants must be authorized to work in the United States on a full-time basis.

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Associate Director, Medical Writing (Regulatory)

Job Description

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