AD, Medical Writing (Home-based)
The Associate Director, Medical Writing will provide expert, hands-on medical writing and QC support for the programs and efforts of the Clinical Development group. This role advises on, develops, and writes clinical and nonclinical documents for regulatory submission from pre-IND through NDA/MAA, as well as other documents for technical/scientific publications. This individual will build and maintain strong working relationships with the Clinical Development, Regulatory Affairs, Preclinical, Global Safety, Biostatistics departments and external collaborators.
- Deliverables include, but are not limited to briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, investigator brochures, clinical study protocols and amendments, model informed consent forms, orphan drug applications, pediatric plans, interim and final clinical study reports, patient narratives, CTD clinical and nonclinical overviews and summaries, safety updates, and integrated summaries of safety and efficacy, along with authoring, co-authoring, updating, and critically editing publications (e.g., manuscripts, review articles, abstracts, poster and presentations) in support of company programs and products
- Accountable for managing the review process for each document, including setting up adjudication meetings with subject matter experts to arrive at resolution, mapping and adhering to timelines for document completion and coordinating with QC, QA, and Regulatory Publishing.
- Perform literature searches/reviews as necessary to obtain background information and training for development of documents
- Participate in electronic document publishing efforts.
- Initiate and manage development of formats, templates, and general guidelines for clinical documentation and workflow procedures
- Ensure that document content and style adhere to ICH/FDA/EMEA or other appropriate regulatory guidelines and comply with departmental and corporate or client SOPs and style guidelines
- Provide independent Quality Control review of documents authored by other writers to ensure accurate, compliant, and submission-ready documents. Documents can include and are not limited to: Clinical Study Protocols and amendments, Informed Consent Forms, Clinical Study Reports, IND/NDA/MAA applications and summaries, Briefing Documents, Investigator Brochures, and regulatory responses.
- Verify the accuracy of document content using source documents including clinical regulatory documents (e. g., protocols, clinical study reports, CIOMS reports, clinical summaries/overviews) and data tables, figures, and listings
- Verify compliance and uniformity of documents with both internal and external standards (e.g., document templates, company style guide, publishing requirements)
- Record QC findings and identify appropriate corrections to address findings
- Verify internal consistency within a document and across related documents
- Collaborate with document authors and other team members, as needed, to resolve QC findings
- Assist in the development of departmental SOPs and guidelines
- Facilitate internal review of materials or documents, and consolidate comments from internal and external reviewers or writers
- Build strategic relationships within the Company and with business partners, vendors, and key external thought leaders to help facilitate involvement with writing activities
- Manage direct reports or contract writers
- Minimum education: Bachelor's degree
- Minimum 10 years' experience in the research, medical, pharmaceutical or biotechnology industry
- Minimum 7 years' relevant medical writing experience and a proven track record in writing a broad range of high-quality regulatory documents
- Recent experience with preparation of NDA/CTD submissions
- Recent experience writing clinical and regulatory documents for oncology products
- Demonstrated knowledge and understanding of business processes, regulatory, and other requirements (e.g., GCP, eCTD, ICH) for Medical Disclosures
- Experience with and working knowledge of clinical trials, clinical development, biostatistics, regulatory, legal, and safety departments
- Ability to analyze, interpret, and communicate data concisely with excellent grammatical precision
- Ability to set objectives and deliver quality results in a dynamic, fast-paced environment
- Expert user of Microsoft Office and working knowledge of Adobe Acrobat
- Ability to learn and use document management systems (e.g., Documentum); experience working in document management systems is a plus
- Excellent organizational, project management and communication skills
- Self-motivated and flexible