What are the responsibilities and job description for the Director Regulatory Medical Writing position at NWRPros?
Responsible for authoring, managing, and editing clinical regulatory documents (e.g., CSR, protocols, IBs), periodic safety reports, clinical submission documents for marketing applications (BLA, NDA, MAA, NDS), and investigational applications (IND, CTA) for our development programs, providing regulatory-compliant documents with consistent messaging and use of program-specific technical terms resulting in well written, reader-friendly documents and applications. Support development of regulatory briefing documents and regulatory response documents. Additionally, oversee outsourced writing performed by vendors and/or contract medical writers.
Essential Duties & Responsibilities:
Education, Experience, Knowledge, and Skills Required:
Behavioral Competencies Required:
Essential Duties & Responsibilities:
- Work closely with clinical and other cross-functional content owners to author, manage, and/or drive the development of high-quality clinical documents, such as investigator’s brochures, clinical protocols, clinical study reports, agency briefing documents, agency response documents, and/or Module 2 overview and summary documents that will be submitted to regulatory authorities such as the FDA, European Medicines Agency, and Health Canada
- Coordinate medical writing resources performed by contract medical writers and/or vendors, including the planning, development, management of cross-functional reviews, reconciling comments with the primary author, editing, QC, and formatting of clinical documents in alignment with Company styles
- Assist in the development and maintenance of templates and guidelines for the standardization of documents
- Assist in the maintenance of the Company Style Guide and provide training to Company employees
- Manage document preparation in accordance with established timelines, including writing, editing, QC, cross-functional review, eCTD readiness for pre-publishing, and final hand-off to document management
- Provide direct writing support for ad hoc projects that may include preparation of abstracts, posters, or other materials for physicians and Medical Affairs
Education, Experience, Knowledge, and Skills Required:
- Bachelor’s degree and a minimum of 7 years as a regulatory writer in the biopharmaceutical industry
- Depth of experience preparing regulatory documents for all types of submissions in electronic Common Technical Document (eCTD) format
- Excellent organizational and/or project management skills
- Solid understanding of FDA/ICH guidelines and GCPs, with a familiarity with GLPs and GMPs
- Excellent technical/regulatory writing skills and strong verbal communication skills
- Expert abilities in Microsoft Office Professional, Adobe Acrobat, and experience with scientific graphing applications
- Adept at version control, formatting, and managing large electronic documents
Behavioral Competencies Required:
- Demonstrated ability to build and maintain positive relationships with management, peers, and subordinates
- Enthusiasm for adapting and learning new skills and helping others to learn and adapt to situations as they evolve
- Strong analytical and problem-solving skills
- Superior attention to detail
