Senior Medical Writer

Location
Menlo Park, CA
Posted
Apr 20, 2022
Ref
4364980004
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Corcept is engaged in the discovery and development of drugs that treat severe endocrine, metabolic, oncologic and neurological disorders by modulating the effects of the hormone cortisol. Since 2012, we have marketed Korlym® for the treatment of patients suffering from Cushing’s syndrome, life-threatening orphan disorder caused by excess cortisol activity.

In addition to our commercial product, Korlym, we have discovered a portfolio of more than 1,000 proprietary selective cortisol modulators.  Lead compounds are in Phase 2 and Phase 3 trials for the treatment of patients with Cushing’s syndrome, advanced ovarian cancer, castration-resistant prostate cancer, weight gain caused by antipsychotic medications and non-alcoholic steatohepatitis (“NASH”).  We are about to start a Phase 2 trial in patients with amyotrophic lateral sclerosis (“ALS”).

In 2020, we generated revenue of $366 million and net income of $112 million.

This position collaborates with cross-functional teams to develop 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.

Essential Responsibilities:

  • Author, co-author, critically edit, and format clinical regulatory documents including NDAs, protocols and protocol amendments, clinical study reports, Investigator’s Brochures, briefing documents, and other regulatory submissions.
  • Interact with document authors, contributors, and reviewers (including members of Biostatistics, Clinical Operations, Clinical Development, Project Management, CMC, Drug Safety, and Regulatory Affairs) to acquire necessary input into documents.
  • Manage medical writing timelines for assigned documents to ensure on-time deliverables that meet business needs.
  • Facilitate comment resolution with authors, reviewers, and project teams.
  • May serve as the functional area representative on project teams and advise such teams on content, format, and style requirements for documents.
  • Participate 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 deliverables.
  • Assist in the interviewing, mentoring, and integration of medical writing staff as needed.
  • Engage in vendor management and provide guidance as needed for execution of assigned tasks.
  • Maintain subject area expertise related to the company’s investigational products, disease indications, and regulatory and publication guidelines.

Preferred Skills, Qualifications or 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.
  • 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 R&D processes and objectives of the required documents.
  • Familiarity with US and Ex-US regulatory requirements and guidelines for documents; general knowledge of 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, Adobe CS, electronic document management systems (e.g., Veeva), and templates (e.g., StartingPoint).

Preferred Education and Experience:

  • BA/BS degree in a scientific field required; advanced scientific degree (PhD, PharmD, or MS) preferred
  • 3 or more 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, and the clinical sections of INDs, and NDAs (including ISS and ISE); and understanding of the content of higher-level summary documents.

Applicants must be currently authorized to work in the United States on a full-time basis.

If you are based in California, we encourage you to read this important information for California residents linked here.

 

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 is an Equal Opportunity Employer