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