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