Associate Director, Medical Writing

Corcept Therapeutics; Redwood City (CA); On-site; USD 190,000 - 223,000; Full time

Job summary

Corcept Therapeutics, headquartered in Redwood City, CA, seeks an experienced Regulatory Medical Writer to author and edit NDAs, protocols, and CSRs for global regulatory submissions. You will collaborate with cross-functional teams to gather inputs and manage timelines in a fast-paced environment.

The role requires 7+ years of regulatory medical writing and deep knowledge of US/EU guidelines, with a BA/BS in a scientific field and an advanced degree preferred.

Qualifications

• BA/BS in a scientific field is required.
• 7+ years of regulatory medical writing in pharma.
• Experience writing clinical study protocols, INDs, NDAs, and CSRs.
• Ability to lead cross-functional teams and manage timelines.
• Knowledge of US/EU regulatory guidelines and eCTD structure.

Responsibilities

• Author and edit NDAs, protocols, CSRs, and investigator brochures.
• Collaborate with Biometrics, Clinical Ops, and Regulatory Affairs to gather input.
• Develop medical writing timelines to ensure on-time deliverables.
• Lead comment resolution and adjudication with authors and project teams.
• Oversee vendors and in-house medical writing staff.
• Represent medical writing on project teams and advise on content, format, and style.
• Develop and refine medical writing processes, SOPs, templates, and style guides.
• Maintain subject-area expertise on investigational products and regulatory guidelines.

Skills

Exceptional writing

Editing complex material

Regulatory knowledge (US/EU)

MS Office & Acrobat

Education

BA/BS in scientific field

Advanced degree preferred

Tools

MS Office

Adobe Acrobat

Veeva Vault

eCTD templates

Job description

For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases.

Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today.

Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com.

Collaborate with colleagues to write 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

• 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
• Interact with document authors, contributors, and reviewers (including members of Biometrics, Clinical Operations, Clinical Development, Project Management, CMC, Drug Safety, and Regulatory Affairs) to acquire necessary input into documents
• Develop and manage medical writing timelines for assigned documents to ensure on-time deliverables that meet business needs
• Lead comment resolution and adjudication with authors, reviewers, and project teams
• Oversee vendors and contractors
• May include management of in-house medical writing staff (based on experience and team need)
• Serve as the functional area representative on project teams and advise such teams on content, format, and style requirements for documents
• 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

Preferred Skills, Qualifications and Technical Proficiencies

• 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 workload based on changing priorities
• Demonstrated initiative and the ability to manage a variety of projects simultaneously with minimal supervision

Preferred Education and Experience

• BA/BS degree in a scientific field required; advanced scientific degree (PhD, PharmD, or MS) preferred
• 7+ years of regulatory medical writing experience in the pharmaceutical industry (or an organization serving them), including experience writing clinical study protocols, clinical study reports, investigator's brochures, clinical sections of Investigational New Drug (IND) submissions and New Drug Applications (NDAs); and understanding of the content of higher-level summary documents

The pay range that the Company reasonably expects to pay for this headquarters-based position is $189,500 - $223,000; 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