Director, Medical Writing at Corcept Therapeutics

Redwood City, California, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Excellent writing skills coupled with good understanding of the drug development process and relevant regulatory guidelines
Ability to write and edit complex material to ensure accuracy, clarity, consistency, and effectiveness
Successful track record of working on complex clinical/regulatory writing projects across multiple therapeutic areas
Excellent attention to detail, multitasking, prioritization, and flexibility
Excellent communication skills with proven ability to interact in a cross-functional environment
Understanding of the drug-development process, including research and development processes and objectives and the required documents
Familiarity with US and European regulatory requirements and guidelines for documents; general knowledge of electronic Common Technical Document (e-CTD) requirements with respect to structure, format, and content
Ability to analyze critically and synthesize complex scientific information from a range of scientific disciplines and clinical therapeutic areas
Proficiency in use of MS Office applications (Word, Outlook, Excel, Powerpoint), Adobe Acrobat, electronic document management systems (eg, Veeva Vault, Box, SharePoint), and templates (eg, StartingPoint)
Comfortable in a fast-paced small company environment with minimal direction and able to adjust

Responsibilities

Provide Medical Writing leadership in strategic project teams as the medical writing subject matter expert, including advising such teams on content, format, and style requirements for documents
Manage in-house medical writing staff, vendors and contractors, providing guidance on prioritization, content, timeline development, and process management
Mentor and support direct reports in the development of their skills and careers
Author, co-author, critically edit, and format clinical/regulatory documents, including New Drug Applications (NDAs), protocols/protocol amendments, clinical study reports (CSRs), Investigator’s Brochures, and other regulatory submissions as needed
Collaborate with document authors, contributors, and reviewers to deliver on clinical documents, including effective communication to manage expectations, resolve issues, and ensure alignment on document timelines and content
Lead the development/refinement of medical writing processes, SOPs, work instructions, templates, style and content guides, and document quality control to ensure efficient preparation of high-quality medical writing deliverables
Maintain subject area expertise related to the company’s investigational products, disease indications, and regulatory and publication guidelines
Perform miscellaneous job-related duties and additional duties and responsibilities as needed

Skills

Key technologies and capabilities for this role

Medical WritingRegulatory SubmissionsNew Drug ApplicationsClinical Study ReportsProtocolsProtocol AmendmentsInvestigator’s BrochuresFDA ComplianceDocument EditingVendor ManagementTeam Leadership

Questions & Answers

Common questions about this position

What are the main responsibilities of the Director, Medical Writing role?

The role involves providing medical writing leadership in strategic project teams, managing in-house staff, vendors, and contractors, authoring and editing clinical/regulatory documents like NDAs and CSRs, collaborating with contributors, and leading the development of medical writing processes and SOPs.

What skills and qualifications are preferred for this position?

Preferred skills include excellent writing skills with understanding of drug development and regulatory guidelines, ability to write and edit complex material for accuracy, clarity, consistency, and effectiveness, and a successful track record on complex clinical/regulatory writing projects.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What is the salary or compensation for the Director, Medical Writing role?

This information is not specified in the job description.

What experience makes a strong candidate for this role?

A strong candidate will have a successful track record of working on complex clinical/regulatory writing projects across various therapeutic areas, excellent writing and editing skills for complex material, and deep knowledge of drug development processes and regulatory guidelines.

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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