Corcept Therapeutics is hiring: Associate Director, Medical Writing (Regulatory)

The Associate Director, Medical Writing (Regulatory) will 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, administrative letters, and other regulatory submissions as neededInteract 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 documentsDevelop and manage medical writing timelines for assigned documents to ensure on-time deliverables that meet business needsFacilitate comment resolution and adjudication with authors, reviewers, and project teamsOversee vendors and contractorsMay include management of in-house medical writing staff (based on experience and team need)May serve as the functional area representative on project teams and advise such teams on content, format, and style requirements for documentsParticipate in 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 deliverablesAssist in the interviewing, mentoring, and integration of medical writing staff as neededMaintain subject area expertise related to the company’s investigational products, disease indications, and regulatory and publication guidelinesPerform miscellaneous job-related duties and additional duties and responsibilities as neededPreferred Skills, Qualifications and Technical Proficiencies : Excellent writing skills coupled with good understanding of the drug development process and relevant regulatory guidelinesAbility to write and edit complex material to ensure accuracy, clarity, consistency, and effectivenessSuccessful track record of working on complex clinical / regulatory writing projects across multiple therapeutic areasExcellent attention to detail, multitasking, prioritization, and flexibilityExcellent communication skills with proven ability to interact in a cross-functional environmentUnderstanding of the drug-development process, including research and development processes and objectives and the required documentsFamiliarity 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 contentAbility to analyze critically and synthesize complex scientific information from a range of scientific disciplines and clinical therapeutic areasProficiency in use of MS Office applications (Word, Outlook, Excel, PowerpointPowerPoint), 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 prioritiesDemonstrated initiative and the ability to manage a variety of projects simultaneously with minimal supervisionAbility to think strategically, be resourceful, and lead without formal authorityPreferred Education and Experience : BA / BS degree in a scientific field required; advanced scientific degree (PhD, PharmD, or MS) preferred8 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 documentsKnowledge of endocrinology, oncology, neurology and / or metabolic disease areas preferredThe pay range that the Company reasonably expects to pay for this headquarters-based position is $181,000 - $213,000; 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.#J-18808-Ljbffr

Salary : $181,000 - $213,000