Associate Director, Medical Writing (Regulatory) at Corcept Therapeutics

Redwood City, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

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

Skills

Medical Writing

Regulatory Documents

IND

CTA

IMPD

NDA

MAA

DSURs

Briefing Books

Clinical Summaries

Non-Clinical Summaries

Document Management

Corcept Therapeutics

Develops cortisol modulators for medical conditions

About Corcept Therapeutics

Corcept Therapeutics focuses on developing treatments that regulate cortisol levels in the body, which is important for managing various health issues. Their main product, Korlym, is used to treat Cushing's syndrome, a condition caused by too much cortisol. Korlym was approved by the FDA in 2012 and is the first medication specifically for this disorder. Corcept stands out from competitors by having a strong emphasis on research and development, having discovered over 1,000 unique cortisol modulators. The company aims to expand its range of treatments while also providing educational resources to healthcare professionals and patients to improve understanding and care for cortisol-related conditions.

Menlo Park, CaliforniaHeadquarters

1998Year Founded

$39.7MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

201-500Employees

Benefits

Remote Work Options

Flexible Work Hours

Risks

Teva's antitrust lawsuit could lead to legal expenses and market share loss.

Heavy reliance on Korlym makes Corcept vulnerable to market fluctuations.

Recent investments may pressure Corcept for short-term financial performance, impacting R&D.

Differentiation

Corcept specializes in cortisol modulation, a niche with few direct competitors.

Korlym is the first FDA-approved treatment for Cushing's syndrome, a significant market advantage.

Corcept's extensive R&D has led to the discovery of over 1,000 selective cortisol modulators.

Upsides

Increased interest in cortisol therapies for mental health boosts Corcept's R&D prospects.

Advancements in drug delivery systems could enhance Corcept's product efficacy.

The FDA's fast-track designation supports Corcept's innovative cortisol-related treatments.

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