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Director, Medical Writing

Job Description:

This position directs the development of high-quality, strategically aligned medical writing deliverables that support the regulatory requirements of a clinical program, ensuring completeness, accuracy, and compliance with US and ex-US regulatory requirements. This position builds strong relationships with Regulatory Affairs, Biostatistics, Clinical Operations, Clinical Development, Project Management, Drug Safety, and other functional areas.


Responsibilities:

  • Author, co-author, critically edit, and format regulatory documents including NDAs, MAAs, INDs, protocols, CSRs, Investigator Brochures, annual reports, briefing documents, and other regulatory submissions
  • Liaise with functional group leads and key stakeholders to ensure appropriate coordination of and input into medical writing activities
  • Manage medical writing resources, both internal and external (eg, independent consultants, CROs, and other communication vendors) across project teams
  • Manage overall medical writing timelines across project teams to ensure on-time deliverables that meet business needs
  • Facilitate comment resolution with authors/reviewers when necessary
  • Serve as the functional area lead on project teams and advise such teams on content, format, and style guide requirements for documents
  • Lead the development 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
  • Manage communication of and training on these processes, SOPs, etc. for internal and contract staff as needed
  • Manage the hiring, supervising, mentoring, and development of internal medical writing staff as the function expands
  • Maintain subject area expertise related to the company’s investigational products, disease indications, and regulatory and publication guidelines
  • Develop and manage a budget for the medical writing function
  • Perform miscellaneous job-related duties and additional duties and responsibilities as needed


Requirements:

  • BA/BS degree in a scientific field required; advanced scientific degree (PhD, PharmD, or MS) or equivalent experience preferred
  • 10 years or more of medical writing experience in the pharmaceutical or biotechnology industry, including experience in the following areas of medical writing: clinical protocols, clinical study reports, Investigator’s Brochure(s), clinical sections of INDs, IMPDs and NDAs (ISS/ISE); experience with submission strategy and content of high-level summary documents
  • Experience with e-CTD and electronic document management systems.
  • Prior experience in a variety of therapeutic areas.
  • Demonstrated supervisory and vendor management experience.
  • Project management experience is essential.


Preferred Skills, Qualifications, or Technical Proficiencies:

  • Excellent writing skills coupled with comprehensive knowledge of the drug development process and regulatory guidelines; ability to write and edit complex material to ensure accuracy, clarity, and effectiveness
  • Excellent attention to detail, multitasking, prioritization, and flexibility
  • Excellent communication skills with proven ability to interact in a cross-functional environment
  • In-depth understanding of the drug development process including R&D processes and objectives and the documents required at each stage
  • Up-to-date knowledge of US and EU regulatory requirements and guidelines for documents; knowledge of e-CTD requirements with respect to structure, format, and content
  • Proficiency in MS Office applications, Adobe Acrobat, and electronic document management systems
  • 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
  • Ability to think strategically; demonstrated negotiating skills and resourcefulness
  • Ability to analyze critically and synthesize complex scientific information from a range of scientific disciplines and clinical therapeutic areas
  • Strong influencing skills; ability to lead without formal authority
  • Successful track record of leading complex clinical / regulatory writing projects
  • Demonstrated ability to make decisions even in the absence of complete information


If you are interested, please submit your resume by email to hr@corcept.com

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