Director, Medical Writing Job at Corcept Therapeutics in Redwood City

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 Director, Medical Writing will collaborate with colleagues to write and / or oversee the development of high-quality, strategically aligned medical-writing deliverables supporting the regulatory requirements of a clinical development program, ensuring completeness, accuracy, and compliance with US and ex-US regulatory requirements.

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

Preferred Skills, Qualifications and Technical Proficiencies :

Preferred Education and Experience :

The pay range that the Company reasonably expects to pay for this headquarters-based position is $172,300 - $253,300; 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.

For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link .

Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.

Corcept is an Equal Opportunity Employer

Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.

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