writer

· Is a capable scientific contributor and subject matter expert in preparation of selected regulatory clinical documentation.

· Applies developing knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects. Participates as part of the medical writing team in cross-functional teams.

· Demonstrates competence in writing, editing and reviewing of clinical study reports, investigator brochures, registration dossier modules, and other clinical regulatory documents in line with expectations.

· Able to interpret data and apply knowledge of regulatory/compliance/scientific requirements to document preparation.

· Manages medical writing projects including the design, planning, and preparation of clinical documentation in support of clinical development, trials, and sections of filings.

· Ability to prepare, with minimal supervision a subset of clinical regulatory documents (e.g., CSR, IB, clinical sections of IND/IMPD and CTD) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format in keeping with industry guidelines

· Participate actively in medical writing and cross-functional project teams.

· Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management.

· Excellent oral (including presentation) and written communication, and project management skills. Awareness of pharmaceutical industry needs beyond clinical development.

All your information will be kept confidential according to EEO guidelines.