The Medical Writer/Senior Medical Writer is responsible for clinical and nonclinical regulatory documents (e.g., study protocols, Investigators Brochures, Clinical Study Reports, Annual Reports, DSURs, IND’s, NDA’s, MAA’s) as well as clinical and non-clinical publications (e.g., Abstracts, posters, and manuscripts).
Primary Duties and Responsibilities:
- Writes clinical protocols, clinical study reports, investigator’s brochures, annual reports, meeting requests, briefing documents, INDs, CTA’s, NDA/MAAs, and other regulatory documents such as ODD, Fast Track, Accelerated, and Priority Review requests in conjunction with the project team with minimal supervision adhering to timelines for document generation, revision, and completion.
- Writes, reviews, and/or edits publications (manuscripts, abstracts, poster presentations, etc.)
- Collaborates with other study team members, coordinates document review cycles, incorporates team comments, and delivers revised/finalized documents.
- Coordinates outsourced writing projects to ensure adherence to ICH guidelines and HUYABIO style guide.
- Implements and maintains writing tools, such as templates and style manuals.
- Completes training on medical writing templates, QS Procedures, SOPs, and processes within the department and across departments.
- Contributes to the development of electronic document systems and tools.
- Provides quality control (QC) review of various regulatory and medical communication documents.
- Takes the initiative to solve problems, exercising sound judgment and appropriate flexibility within a dynamic environment.
- Undertake research in the therapy area and regulatory environment to allow effective writing.
- Acts as an authoritative resource within specialty areas to internal and external resources.
- Works effectively with colleagues from other departments in team situations.
- Bachelor’s degree in a clinical, scientific, or industry-related field; Advanced degree for Senior Medical Writer
- Familiarity with Endnote reference program, document control systems (Veeva), document templates, regulatory requirements for preparation of key regulatory documents
- Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, and medical terminology
- Excellence in advanced features of Microsoft Word, Office 365, Adobe Acrobat, spreadsheet programs
- Documented skill in regulatory writing, scientific publications