This position 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
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
- 10+ years (Director) of regulatory medical writing experience in the pharmaceutical industry (or an organization serving them), including experience managing a team and 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 $183,500 - $242,800; 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.
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.
Please visit our website at: https://www.corcept.com/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.
